&EPA
M Protection
Agtncy
Offieaof
Pwtlcidw and Toxie SufaAancw
WMhington DC 20480
October 1987
PMicidM
Guidance for the
Reregistration of
Pesticide Products
Containing AMITRAZ
as the Active Ingredient
-------
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
AMITRAZ
AS THE ACTIVE INGREDIENT
EPA Case No. 234
CAS NUMBER 33089-61-1
October 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
-------
TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard .... . . .... 4
A. Description of Chemical
B. Use Profile
III. Regulatory Position and Rationale 13
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
IV. Products Subject to this Standard 27
V. Requirement for Submission of Generic Data 29
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancella tion
VII. Requirement for Submission of Product-Specific Data . . 35
VIII. Requirement for Submission of Revised Labeling 36
IX. Instructions for Submission 36
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
-------
APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Generic Data Exemption Statement
-------
I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration--Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies;
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request^, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
J-The scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
" 1
-------
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. -See
Regulatory Position and Rationale section. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrationsi
in compliance with FIFRA. These steps may include:
.1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicologies
and environmental characteristics and fate of a pesticide.•
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify
-------
the"Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. T'his requirement continues
as long as the products are registered by the Agency.
-------
II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical and Use Profile
Amitraz is the American National Standards Institute's (ANSI)
acceptable common name for N'-(2,4-dimethylphenyl)-N-[[(2,4-
dimethylphenyl)imino]methyl]-N-methylmethanimidamide. Other
names and code designations are: Estrella, Azadieno, Baam,
Mitac, Taktic, JA 119, Triazid, Triatox and Azaform. The
current Chemical Abstract Service (CAS) registry number for
amitraz is 33089-61-1 and the EPA Shaughnessy number is 106201.
Technical amitraz is a straw colored crystalline solid. Its
melting point is 86-87°C. Amitraz at 25°C is extremely
soluble in xylene (66.6g/100ml) and acetone (50g/ 100ml) and
re-latively insoluble in methanol (2.38g/100ral) and water
(
-------
on pears, ticks on cattle and lice on hogs. There are proposed
tolerances and applications for registration for apples and
citrus. Amitraz is currently a restricted-use pesticide and
applicators must be certified or be under the direct supervision
of applicators certified to apply amitraz. However, the Agency
has reevaluated the basis for the restricted use designation and
determined that it is not warranted as described below in section
C '('4).
B. Regulatory Background
Amitraz was first registered in 1975 as a 93% technical to be
used in the preparation of experimental miticide/insecticide
formulations. The first application for registration for an
end-use product for use on apples and pears was made in 1976.
In April 1977, before the registration of these uses, the Agency
published in the Federal Register (42 FR 18299) a notice of a
rebuttable presumption against registration (RPAR, and currently
known as a Special Review) of pesticide products containing
amitraz on the ,basis that amitraz met the risk criteria for
oncogenic effects (40 CFR 162.11(a)(3)(ii)(A)). An 80-week mouse
oncogenicity study showed a significant increase in the incidence
of lymphoreticular tumors in mice.
In January, 1979, the Agency published in the Federal Register
(44 FR 2678-2632) a notice of determination and availability
of Position Document 2/3. This position document presented the
Agency's analysis of the risks and benefits resulting from the
-------
proposed use of amitraz on apples and peacs, analyzed the-
rebuttals received from interested parties and proposed a
decision to conclude the RPAR process. The Agency concluded
that there is "weakly positive evidence" that amitraz is a
possible human carcinogen based on the positive effects
demonstrated in the mouse study although there were questions
raised regarding the reliability of the study. The Agency
also concluded that the proposed use of amitraz on apples-^and
pears might pose a very small risk of cancer to certain exposed
groups. To determine that risk the Agency conducted a dietary
and occupational risk assessment.
The Agency, in its assessment of dietary and occupational risks
associated with the use on pears, calculated two scenarios for
exposure, one conservative an.d the other more realistic. The
conservative scenario used the assumptions that: all pears were
treated annually; all fresh and processed pears had residues of
of amitraz at the tolerance level (3.0 ppm); and mixers, loaders
and applicators did not wear protective clothing. These
conservative assumptions led to calculated risks of 9 x- 10~6
(10~5) from dietary exposure and 10~4 to 10~6 from occupational
exposure. The more realistic scenario included the following
assumptions: only 40-50% of the pear acreage is treated annually,
fresh pears average 1.0 ppm and processed pears average 0.25 ppm
of amitraz residues and mixers, loaders and applicators are
required to wear protective clothing. This more realistic
scerMrio leads to risks of 10~6 for dietary and 10~5 to 10~6
-------
for occupational exposure. In reviewing the benefits and
risks, the Agency determined that there would be significant
benefits from the use on pears since there was no viable
registered alternative to amitcaz for control of the pear
psylla. However, there were little or no benefits from
the use on apples since there were suitable alternatives.
After weighing the benefits and risks, the Agency in the
PD 2/3 proposed to issue a conditional registration for four
years for use of amitraz on pears provided that the company
agreed to certain terms and conditions. These were (1) to
submit additional benefits data on pears, (2) submit a new
mouse oncogenicity study and (3) implement several changes
on the proposed label. The label changes were: classification
of all amitraz products as restricted use; additional
precautionary changes including protective clothing for
applicators; and, a 24-hour reentry interval and a 7-day
pre-harvast interval.
2. Conclusion of RPAR
In October, 1979, the Agency published in the Federal Register
(44 FR 59939-59946) a notice of its intent to conditionally
register amitraz for use on pears and not to issue registration
for use on apples. This FR Notice also announced the avail-
ability of Position Document 4. In this notice the Agency
proposed to conditionally register amitraz for use on pears
for four years under section 3(c)(7)(C) of FIFRA with the
conditions that the registrants make certain label changes
-------
and that an additional mouse oncogenicity study and benefits
data be submitted within four years from the date of registration.
This section of FIFRA allows conditional
registration of a pesticide product containing unregistered
active ingredients only if the registration would not cause
unreasonable adverse effects and would be in the public
in-terest. The Agency determined that the registration of
amitraz for use on pears would not cause unreasonable adverse
effects and would be in the public interest because it would
result in substantial benefits which outweighed risks. The
Agency determined that it could not grant registration of
amitraz for use on apples because the requirements of section
3(c)(7)(C) of FIFRA had not been met. The Agency concluded
that this use would result in little or no benefits and would
therefore not be in the public interest. Amitraz was granted a
conditional registration in January, 1980, for four years only
for use on pears. At the same time, the Agency established a
0.0 ppm tolerance for residues of amitraz in or on apples, and
the fat, meat by-products, and meat of cattle, goats, hogs,
horses, and sheep to effect the decision to prohibit the use on
apples. (Waste from processed apples is fed to livestock.)
3. Reassessment Based on New Data
The conditions under which amitraz was conditionally registered
have been satisfied. The benefits data were reviewed and found
to substantiate the benefits of the use on pears. A new mouse
oncogenicity study was referred to the Agency's Cancer Assessment
8
-------
Group (CAG) for evaluation. The results of this study showed an
increase in the incidence of hepatocellular tumors in female mice,
Based on this study and the first mouse study, CAG determined
that amitraz had carcinogenic activity in the mouse. The
second study did not appreciably change the Agency's quantitative
assessment of the potency of amitraz from the first mouse study.
Based on the weight of evidence, CAG concluded that amitraz
should be considered a possible human carcinogen in the lower
portion of the group "C" range. In reaching this conclusion CAG
considered the following information:
There is no positive epidemiology carcinogenicity data for
amitraz.
The positive carcinogenic effects were found in only one species,
the mouse.
Tumors were discovered mostly in terminally sacrificed groups. '
The rat was negative for oncogenic effects at doses as high as
200 ppm.
Also, the mutagenic potential of amitraz had been determined
to be negative in the gene mutation, hostmediated and dominant
lethal test systems. Additional negative studies including
the Ames Bacterial Test, a Mouse Lymphoma Assay, and an
Unscheduled DNA Synthesis in Human Embryonic Cells have been
conducted with amitraz. In addition, several metabolites were
also tested with their mutagenic potential also reported to
be generally negative. The Agency is not aware of any other
pesticide that is structurally related to amitraz that shows
carcinogenicity. However, the parent compound does metabolize
to substituted anilines, some of which as a class are oncogenic.
-------
The chronic toxicology data base for amitraz is complete. The
toxicological data considered in support of this registration
standard included a 2-year rat feeding/oncogenicity study which
was negative for oncogenic effects with a no-observable-effeet-
level (NOEL) of 200 ppm; a three-generation rat reproduction
study with a NOEL of' 15 ppm; rat and rabbit teratology studies
which were negative; and a 2-year mouse oncogenicity study
which demonstrated an increase in the incidence of hepatocellular
tumors in female mice.
4. Presentation to the Scientific Advisory Panel
On February 12, 1986 the Agency presented its conclusions and
rationale to the FIFRA Scientific Advisory Panel (SAP) on the
carcinogenic! ty of amitraz. The Agency stated that it.
"recognizes that Group C covers a broad range of oncogenic
properities of limited evidence in animals and views amitraz
to be in the lower portion of the Group C range". This means
the classification is near the C/D interface for which no
clear evidence of oncogenic potential has been demonstrated.
Industry also presented its position which included their view
that (1) the second mouse study may have exceeded the maximum
tolerated dose and therefore compromised the mice physiologically
and (2) data support the hypothesis that there is an indirect
hormonal mechanism for tumorigenesis at the high dose which dose
which does not exist a lower doses.
After considering all of the evidence and presentations, the SAP
10
-------
concluded that amitraz should be classified in Group "D", (not
classifiable as to human carcinogenicity) because they believed
the weight of the evidence was inadequate to clearly categorize
the oncogenic potential of amitraz.
The Agency has reassessed its own position in light of the
industry presentations and the SAP opinion and has now concluded
that amitraz is a borderline Class C/D carcinogen considering the
following information:
0 the increase in liver tumors is found in only 1 sex, one species,
and one dose, i.e., female mice at the high dose only-
0 a two year acceptable rat oncogenicity study is negative for
oncogenic potential;
0 there is an essentially negative gene toxicity data base;
0 the high dose administration in the second mouse study may
have exceeded the maximum tolerated dose (MTD) and therefore
compromised the females physiologically;
0 data presented support an indirect hormonal mechanism for
tumorigenisis at the high dose which may not be operative at
lower doses.
For the same reasons stated above, the Agency believes that a
quantitative risk assessment for amitraz would not provide
useful enough information on which to base a reasonable
regulatory decision. Therefore, a quantitative risk assessment
will not be performed. The risks from use of amitraz can only
be assessed in a qualitative way; i.e., there is weak evidence
that amitraz may be a carcinogen in laboratory animals and
therefore may pose some unquantifiable risk to people exposed
to amitraz through the diet or during application.
11
-------
In this registration process the Agency has reconsidered the
risks and benefits associated with the use on pears in view of
the reassessment of the data base including the new oncogenicity
study and benefits data. The assessment of these data has led
the Agency to change its opinion of amitraz'z oncogenic potential;
i.e., it is a Class C/D carcinogen instead of a Class C carcinogen.
The benefits of use of amitraz remain essentially the same and the
benefits outweigh the qualitative risks.
12
-------
III. REGULATORY POSITION AND RATIONALE
A. Summary Of Regulatory Position and Rationales
Based on a review and evaluation of all available data and other
relevant information on amitraz, the Agency has made the following
determinations:
1. All products containing amitraz as a sole active ingredient
may continue to be registered or sale, distribution,
reformulation, and use on pears, cattle and hogs subject
to the terms and conditions specified in this Guidance
Document. Registrants must provide, or agree to develop,
additional data, as specified in Tables A and B in order to
maintain existing registrations or to permit new registrations.
Rationale; Under FIFRA, the Agency may choose not to cancel or
withhold registration if data are missing or are inadequate
(see FIFRA sec. 3(c)(2)(B) and 3 (c)(7)). The issuance of this
standard provides a mechanism for identifying data needs. These
data will be reviewed and evaluated, after which the Agency will
determine if additional regulatory actions are necessary. In
addition, the Agency made a regulatory decision in 1980 to
conditionally register amitraz for use on pears because a
risk/benefit assessment demonstrated that the benefits from
the use outweighed the risks. A current evaluation of the
benefits from the use of amitraz on pears indicates that
the benefits have not changed. No viable alternative to
amitraz for control of the pear psylla has been registered
by the Agency since the original benefits assessment. The
13
-------
Agency has since registered amitraz for use on hogs and
cattle. As discussed above, the Agency has not quantified
the risks due to the use of amitraz but has reevaluated
the evidence which indicates it to be a Class C/D carcinogen.
Although exposure to amitraz may pose some unquantifiable
oncogenic risk, the Agency believes it continues to be in
the best interest of the public to continue the registration
of amitraz; the benefits of use of amitraz outweigh the
qualitative risks.
2. The Agency cannot issue tolerances for the proposed use of
amitraz on apples and citrus at this time. The Agency will
consider new uses for amitraz on a case-by-case basis.
Rationale:
The toxicology data base for amitraz is complete. The
environmental data base for amitraz is largely incomplete.
However, there are uses which would have minimal impact on
the environment. Available residue data submitted in
support of the proposed apple and citrus uses indicate
that food additive (409) tolerances for apple pomace and
citrus molasses and pulp must be established. There is
weakly positive evidence that amitraz is a carcinogen. At
this time the Agency can not establish these food additive
tolerances because of the Delaney Clause within Section
409 of the Federal Food, Drug and Cosmetic Act. The Dela'ney
Clause in Section 409 of the FFDCA bars the establishment
of food/feed additive regulations for substances which induce
14
-------
cancer in man or test animals, with certain exceptions. The
Agency is currently developing a position relative to the
Delaney Clause and FIFRA. Once this policy has been
established, the proposed apple and citrus tolerances will be
reevaluated. Other uses will be evaluated on a case by
case basis.
3... The Agency is requiring environmental fate studies to
characterize amitraz's fate in the environment, including
its potential to leach through soil.
Rationale; Data are not sufficient either to assess the
environmental fate of amitraz or to characterize its leaching
potential for contamination of ground water. The preliminary
data indicate that amitraz may have the potential to leach
through soil. A leaching study (although not adequate by
Agency standards) indicates that amitraz is moderately mobile
in sandy loam, silt loam and clay soils and very mobile in
sandy soils. Additional studies are being required. The
Agen-cy has become increasingly concerned about-the presence
of pesticide chemicals in ground waters in the United States.
Although amitraz was not included in the Special Data Call-in
Notice the Agency issued on March 31, 1984 the Agency is
concerned over the potential of amitraz to leach. The data
required under this Guidance Document will allow the Agency
to characterize the potential of amitraz to contaminate
ground water.
15
-------
4. The Agency has determined that end use product-s containing
amitraz will no longer be classified as restricted use
products.
Rationale; The Agency required that all end-use amitraz
products be classified for restricted use when amitraz was
conditionally registered for use on pears in an effort to
reduce worker exposure. However,- upon reassessment of the
carcinogenic potential of amitraz, the"Agency has concluded
that it is a borderline Class C/D carcinogen, on the line
between "possible human carconogen" and "not classifiable
as to human carcinogenicity" (the animal evidence is inadequate)
Therefore, because the hazard could not be well defined, a
quantitative risk assessment would not be appropriate.
Because of this reassessment, the Agency believes it would be
unreasonable to restrict the use of amitraz, since the weight
of the evidence is inadequate to clearly catagorize the
oncogenic potential. Continuation of the restricted use
classification is not warranted. Because there are no other
reasons to restrict amitraz products at this time, the
Agency via this Standard is removing the restricted use
classification for amitraz end-use products. For the same
reasons, the Agency will not impose a cancer label warning
for amitraz products; the evidence does not warrant such
a warning.
16
-------
5. The Agency will continue to require a reentry interval of
24 hours for the pear use of amitraz.
Rationale; Amitraz meets the toxicity and exposure criteria
for reentry as defined under the Pesticide Assessment
Guidelines. In order to minimize exposure of this acutely
toxic pesticide to workers entering treated areas pending
the receipt and evaluation of reentry data, the 24-hour
reentry interval will be continued. Through this Guidance
Document studies are being required to further evaluate
amitraz's exposure potential. Upon receipt and review
of these data, the Agency will reevaluate the reentry
interval established for amitraz.
6. The Agency is requiring a study to determine the effects of
amitraz on avian reproduction.
Rationale; Acute toxicity studies indicate that amitraz
is slightly toxic to birds. A one-generation avian
reproduction study, although inadequate, demonstrated that
amitraz would affect avian reproduction at less than 40 ppm.
A NOEL was not established with that study. Therefore, a new
study is being required. Also, sufficient environmental fate
data are not available to permit assessment of avian exposure
to amitraz residues. Based on Agency receipt and review of
the avian reproduction data and the environmental fate data
required by this Guidance Document, the Agency will be able
to determine if amitraz poses a hazard to bird reproduction.
17
-------
7. The Agency is requiring additional plant metabolism data since
the metabolism of amitraz in plants has not been adequately
described.
Rationale: Heretofore, the parent compound, amitraz and its
metabolites containing the 2,4-dimethylaniline moiety have
been considered to be the residues of concern in plants.
However, reexamination of existing data indicate that about
60% of the residues were unidentified. Should the required
metabolism data indicate the presence of additional
metabolites of concern, the tolerance definition will have
to be altered accordingly. In addition, the Agency is
concerned over the possibility of amitraz to hydrolyze and
form dimethylamine which has been shown to cause liver
tumors in mice. The Agency cannot determine whether amitraz
does hydrolyze to dimethylamine and if so, the amount, until
the plant metabolism data are submitted.
8. The Agency is not imposing label statements at this time
with regard to endangered species.
Rationale; The limited available data indicate that technical
amitraz is slightly toxic to birds. Although an avian repro-
duction study indicates a potential chronic hazard to birds
is possible if there is sufficient exposure from the use of
amitraz, the effect on birds including endangered species
cannot be assessed until a new avian reproduction study and
the environmental fate data required by this Guidance Document
18
-------
are received and evaluated. The available data also suggest
that the estimated residues that could occur in water as a
result of the pear use of amitraz do not result in an endangered
aquatic species concern. The Agency will address the need
for an endangered species label statement when the environmental
fate and avian reproduction data are received and evaluated.
9. Registrants of end-use products must submit revised labeling
which incorporates the label precautions found in Section G.
Rationale; The Agency believes that the label statements
prescribed in this Standard should minimize the hazards
associated with exposure to users of amitraz and to
aquatic organisms.
19
-------
B. Criteria for Registration Under This Standard
To be covered under this Guidance Document products must
contain amitraz the sole active ingredient, bear required
labeling," and conform to the product composition, acute
toxicity limits, and use pattern requirements listed in
Section F of this document.
The application for registration or reregistration of manufac-
turing-use products subject to this Guidance Document must
comply with all terms and conditions described in it, including
submission of an up-to-date Confidential Statement of Formula,
submission of revised labeling, commitment to fill data gaps
on the schedule specified by the Agency and, when applicable,
offer to pay compensation as required by 3(c)(l)(D) and
3(c)(2)(D) of the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA), as amended, 7 U.S.C. 136{c)(l)(D) and 136(c)(2)(D).
20
-------
C. Acceptable Ranges and Limits
1. Product Composition Standard
To be covered under this Guidance Document manufacturing-use
products must contain amitraz as the sole active ingredient.
Each manufacturing-use product formulation proposed for
registration must be fully described with an appropriate
certification of limits, stating maximum and minimum
amounts of the active and intentionally added inert
ingredients which may be present in products.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
• and manufacturing-use products containing amitraz provided
that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which each
product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products containing amitraz may be labeled for formulation
into other manufacturing-use products or into end-use
products only for the use on pears. The attached index
entry provides the approved maximum application rate and
frequencies.
21
-------
D. Required Labeling
All manufacturing-use and end-use amitraz products must bear
appropriate labeling as specified in 40 CFR 162.10, PR Notices
83-2, 83-3, 37-4, 87-5, and below. Appendix II contains further
information on label requirements.
Pesticide products containing amitraz as the active ingredient may
not be released for shipment by the registrant after October 31, 1983
unless the product bears amended labeling which complies with the
requirements of this standard.
Pesticide products containing amitraz as the active ingredient may
not be distributed, sold, offered for sale, held for sale, shipped,
delivered for shipment, or received and (having been so received)
delivered or offered to be delivered to any person after October 31,
1989 unless the product bears amended labeling which complies with
the requirements of this Standard.
All Products
1. Ingredient Statement
The ingredient statement for manufacturing-use products and
end-use products must list the active ingredient as:
Amitraz: N'-(2,4-dimethylphenyl)-N-[[2,4-dimethylphenyl)=
imino]methyl]-N-methylmethanimidamide
22
-------
Manufacturing Use Products
1. Use Pattern Statement
All manufacturing-use amitraz products must state that they
are intended for formulation into other manufacturing-use
products or into end-use products for use only on pears.
2. Environmental Hazards
The following revised environmental hazard statement must appear
on all MP labels:
"This pesticide is toxic to fish. Do not discharge
effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or public water unless this
is specifically identified and addressed in an NPDES
permit. Do not discharge effluent containing this
product into sewer systems without previously notifying
the sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office
of the EPA."
End-Use Products
1. Reentry Statement
The reentry statement below must appear in the use directions
of labels of all amitraz products with directions for use
for use on pears:
"Do not reenter treated areas for 24 hours without
protective clothing."
23
-------
2. Protective Clothing and Equipment
The worker protection statements listed below must appear as
part of the precautionary statements for all end-use amitraz
products:
"During mixing/loading or application wear a protective
suit which has long sleeves and long pants. Wear chemical
resistant gloves; a hat, boots and goggles or face
shield. A helmet with visor may be substituted for the
hat and goggles during aerial application. Mixer/loaders
should also wear a chemical resistant apron when handling
the concentrated product. Wash thoroughly with soap and
water after handling and before eating, urinating,- or
smoking. Remove and wash clothing before reuse. Clothing
should be laundered separately from household articles.
Replace gloves frequently. Clothing which has been
drenched and used gloves should be disposed of in accor-
dance with state or local regulations. Instead of
clothing and equipment specified above, the applicator
can use an enclosed tractor cab or cockpit with properly
filtered air supply."
3. Environmental Hazards
The following environmental hazards statement listed below
must appear on each end-use label in the Environmental Hazards
section:
"This product is toxic to fish. Do not apply directly
to water. Drift and runoff from treated areas may be
hazardous to fish in adjacent sites. Do not contaminate
water by cleaning of equipment or disposal of wastes."
24
-------
E. Tolerance Reassessment Summary
U.S. tolerances for residues of amitraz in or on the raw agricul-
tural commodities are as follows:
3.0 ppm in or on pears
0.1 ppm cattle, fat
0.3 ppm cattle, mbyp
0.05 ppm cattle, meat
0.03 ppm milk
0.3 ppm milk, fat
0.1 ppm hogs, fat
0.2 ppm hogs, kidney and liver
0.3 ppm hogs, mbyp
0.05 ppm hogs, meat
0.0 ppm in or on apples, and the fat, meat by-products,
and meat of goats, horses, and sheep
The zero tolerances were established administratively as a result
of the RPAR as an affirmative action to emphasize the Agency's
decision_not to permit the use of amitraz on apples.
Interim Codex Maximum Residue Limits have been established
for amitraz as follows: in or on pome fruits at 0.5 ppm; in
or on oranges at 0.5 ppm; and, in or on the carcase meat of
cattle and pigs at 0.05 ppm, cattle, pig, and sheep meat
by-products at 0.2 ppm and milk at 0.01 ppm. There are no
Canadian or Mexican tolerances established for amitraz. The
metabolism of amitraz in plants has not been adequately
25
-------
described. Should the required metabolism .data indicate the
presence of additional metabolites of concern, the tolerance
definition will be revised accordingly. The available pear
residue data support the established tolerance level for
amitraz residues in or on pears.
There are no finite tolerances established for amitraz residues
on .crops involving livestock feed items. At this time, data
pertaining to the metabolism of amitraz in^fobd animals for
purposes of this Registration Standard are not required.
The acceptable daily intake (ADI) for amitraz is 0.0025 mg/kg/day
based on the 2-year chronic dog feeding study with a no observed
effect level (NOEL) of 10 ppm and a safety factor of 100.
The maximum permitted intake (MPI) (based on-a 60 kg person)
is 0.15 mg/day. The theoretical maximum residue contribution
(TMRC) resulting from the published tolerancesis 0.0723 mg/day
which accounts for 48.20% of the ADI.
26
-------
IV. PRODUCTS SUBJECT TO THIS .STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whet&er ^the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A.-' Manufacturing use products containing amitraz as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and 8^
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
27
-------
B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole_ active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formula tor's exemption^, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section III.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for th-e formulator's exemption, the
data requirements listed in Table C.
If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownershio
in common witn yours, you individually lose the exemption '
and become subject to the data requirements in Table A.
in TaKi lf n° producec subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
28
-------
V. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must.submit generic data?
All current registrants are responsible for-submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, riot to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide, the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
29
-------
If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source^of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the.application is submitted, the data have been submitted
to''the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency-
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)jB) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of: your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
30
-------
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the_members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
31
-------
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may. qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not(or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
32
-------
E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part,158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the -studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W.,. Washington, D.C.
20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you 'must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
33
-------
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a ti.ne extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believa that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin-proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
34
-------
such permission would be consistent with the.Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stoc.ks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
• •-VI. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section V.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or V.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
35
-------
VII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
VIII. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3 (c).( 2) (B ) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. -Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.
36
-------
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
^—— b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
. inch paper or a mockup of the labeling suitable for
' storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
3. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 3570-27),
if applicable.
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
37
-------
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 3570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
. if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling -should
be either typewritten text on 8-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
38
-------
E. Addresses
The required information must be submitted to the following
address:
Dennis H. Edwards, Jr. PM 12)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
39
-------
APPENDIX I
DATA APPENDICES
40
-------
TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End- use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table
APPENDIX I rr-
-I- ' 41
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
??STIF
APPENDIX''T*
-2-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
Guideline Citation and Test Guidelines Are Data Footnote
Name of Test Substance* Status Required Number
Yes No
§158.120 Product Chemistry
Product Identity:
61-2 - Description of Beginning Materials TGAI R [X] M 3
and Manufacturing Process
61-3 - Discussion of Formation of TGAI R [X] [~] 4
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis TGAI CR [X] M 5
Physical and Chemical Characteristics
63-2 - Color TGAI R M [X]
Data Must Be
Submitted Within
Time Frames Liste
Below ^
6 Months
6 Months
12 Months
63-3 - Physical State TGAI R M [X]
63-4 - Odor TGAI R [X] [~]
6 Months
63-5 - Melting Point TGAI R M [X]
63-6 - Boiling Point TGAI R M [X] 6
^ APPENDIX I
-3-
-------
TABLE A
GENERIC DATA REQUIREMENTS EOR CHEMICAL: AMITRAZ
Guideline Citation and
Name of Test
Test Guidelines Are Data 'Footnote
Substance Status Required ,' Number
Yes No
Data must Be
Submitted Within
Time Frames Listed
Below 1
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7
63-8
63-9
63-10
63-11
63-12
63-13
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
coefficient
- pH
- Stability
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
R
R
R
R
R
R
R •
[X] [ ]
[~] [X]
M IX]
M [X]
[xj n
[xi n
tx] n 7
6 Months
6 Months
6 Months
15 Months
Other Requirements;
64- 1 - Submittal of samples
TGAI, PAI
CR
[~]
IX]
APPENDIX I
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.120 Product Chemistry (Continued)
1. TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient; R = Required; CR = Conditionally Require
2. Data must be submitted within the indicated time frame/ based on the date of the Guidance Document.
0 6 Month Due Date is .
0 15 Month Due Date is .
3. Details of the manufacturing process including the relative amounts of beginning materials, description of
reaction conditions, duration of each step of the process and quality control measures for the stabilized
93% technical must be submitted. The name and address of the manufacturer or producer of each starting
material for the stabilized 93% technical must be submitted. In addition, a copy of all available technical
specifications, data sheets, and all other documents by which the manufacturer, producer or supplier of the
beginning material describes its composition and properities must be submitted.
4. A discussion of each impurity believed to be present at >0.1% based on knowledge of any contamination such as
migration of components of packaging materials into the product and contaminants resulting from earlier use
of production equipment to produce other products or substances must be submitted.
5. Five or more representative samples should be analyzed for the amount of active ingredient and each impurity
present >0.1%. Analysis for nitrosoamine impurities should include volatile and non-volatile
nitrosoamines.
6. Not required because the 93% stabilized technical is a solid at room temperature.
7. Insufficient information was provided as to the sensitivity of the 93% stabalized technical to metal ions and
metal, therefore additional data are required.
CD
APPfTCDIX T
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frames For Data
Submission 2
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
Requirement?
Bibliographic
Citation
§158.125 Residue Chemistry
171-2 - Chemical Identity TGAI
171-3 - Directions for Use
171-4 - Nature of Residue (Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical Method
- Plant residues
- Animal residues
- Storage stability
171-4 - Magnitude of the Residue-
Residue Studies for Each
FtxxJ Use
- Pears TEP
PAIRA
PAIRA and Plant
Metabolites
TGAI and Metabolites
TGAI and Metabolites
TGAI and Metabolites
Yes
Yes
Partial
NO
Yes
Partial
GS00234015;GS00234016 No
GS00234017 No
00028664,-00028666
00055718;GS00234011
GS00234012
00046030;00051930
00051929;GS00234013
00046029;GS00234014
Yes3 18 Months
Reserved^
No5
Reserved4
Yes6 15 Months
Yes
00046029 ,-00051717
No
ON
APPENDIX I
-6-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement?
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frames for Data
Submission 2
§158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue -
Residue Studies (continued)
— Meat/MiIk/Poultry/Eggs
TGAI or Plant
Metabolites
No
Reserved^
171-5 - Reduction of Residue
171-6 - Proposed Tolerance
171-7 - Reasonable Grounds in
Support of Petition
171-13 - Submittal of Analytical
Reference Standards
Residue of
Concern
Residue of
Concern
PAIRA
No
No
No
Yes
No7
No7
No7
No7
APPENDIX I
-7-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.125 Residue Chemistry - Continued
1. Composition: TGAI - Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP
Typical end-use product; EP = End-use product.
2. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 15 Month Due Date is .
0 18 Month Due Date is .
3. The available plant metabolism data are not adequate because a large fraction (>60%) of !4C-residues recovered
from mature pears was not identified. Data reflecting the distribution and metabolism of l^C-amitraz labeled
in both benzene rings in mature pears harvested 7 days after the last of a series of prebloom and foliar
applications (at least 10) at l.Slb. AI/A is required. It may be necessary to apply exaggerated rates to
obtain sufficient residues for identification. Analyses should include hydrolysis and reextraction of plant
residues and aqueous fractions to determine conjugated 14oresic|ues of amitraz. ^C amitraz treated pears
should also be analyzed by enforcement "cold" methodology to determine whether conjugated metabolites of
concern are determined by the method and to verify detection of all 2,4-dimethylaniline.
4. There are no finite tolerances established for amitraz residues on crops involving livestock feed items.
Therefore, data are not required at this time.
5. If additional metabolites of toxicological concern are found then additional validated methods for data
collection and tolerance enforcement will be required.
6. Data are required reflecting the stability of metabolites III, IV, and V in or on pears stored at freezing
temperatures for intervals up to 42 days.
7. Not applicable.
APPENDIX I
4^. -8-
OO
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL:
AMITRAZ
1 Use 2
Data Requirement Composition Pattern
i
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI or PAIRA A
Photodegrada tion
161-2 - In water TGAI or PAIRA A
161-3 - On soil TGAI or PAIRA A
161-4 - In Air TGAI or PAIRA A
1 METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA A
v£> 162-2 - Anaerobic Soil TGAI or PAIRA A
162-3 - Anaerobic Aquatic TGAI or PAIRA A
162-4 - Aerobic Aquatic TGAI or PAIRA A
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA A
Adsorption/Desorption
163-2 - Volatility (Lab) TEP A
163-3 - Volatility (Field) TEP A
Does EPA Have
Data To Satisfy
This Require-
ment?
No
No
No
No
No
No
No
No
Partial
No
No
Must Additional Data
Be Submitted Under
Bibliographic FIFRA § 3(c)(2)(B)?
Citation Time Frame for Data
Submission 3
Yes
Yes
Yes
No4
Yes
Yes
No4
No4
00114229 Yes5
Yes
Yes
9 Months
9 Months
9 Months
27 Months
27 Months
12 Months
12 Months
15 Months
APPENDIX I
-------
TABLE A
GENERIC DATA REQUIREMENTS POR CHEMICAL
AMITRAZ
Data Requirement
§158.130 Environmental Fate -
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Targe
1
Composition
Continued
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
st TEP
Does EPA Have
Data To Satisfy
Use 2 This Require- Bibliographic
Pattern ment? Citation
A No
A No
A No
A No
A No
A , No
A No
A No
A No
A No
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3
Yes
No4
No4
No4
No4
No4
No4
No4
Yes
Yes
27 Months
12 Months
12 Months
Organisms
CD
APPENDIX I
-10-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.130 Environmental Pate - Continued
1. Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2. The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 9 Month Due Date is .
0 12 Month Due Date is .
0 15 Month Due Date is .
0 27 Month Due Date is . .
4. Not required based on use pattern.
5. Although this study is scientifically sound, this study does not fulfill this data requirement because of the
following deficiencies: the test soils were not completely characterized; the purity of the test substance was
not reported; the incubation temperature was not reported; degradates were not identified; and values of soil/
water relationships (K^) were not reported. This information must be submitted to upgrade the study or
another study must be conducted.
APPENDIX I
-11-
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL:
AMITRAZ
1 Use 2
Data Requirement Composition Pattern
§158.135 Toxicology
ACUTE TESTING:
81-1 - Acute Oral Toxicity - Rat TGAI A
81-2 - Acute Dermal Toxicity TGAI A
Does EPA Have
Data To Satisfy
This Require-
ment?
Yes
Yes
Bibliographic
Citation
00041539
00040862
Must Additional Data
Be Submitted Under
FIFRA § 3(C)(2)(B)?
Time Frame for Data
Submission 3
No
No
- Rabbit
81-3 - Acute Inhalation Toxicity TGAI
- Rat
81-7 - Delayed TGAI
Neurotoxicity - Hen
SUBCHRONIC TESTING;
82-1 - 90-Day Feeding : TGAI
- Rodent, and
- Non-rodent (Dog)
82-2 - 21-Day Dermal - Rabbit TGAI
82-3 - 90-Day Dermal - Rabbit TGAI
82-4 - 90-Day Inhalation: TGAI
- Rat
82-5 - 90-Day Neurotoxicity: TGAI
- Hen
r, -Mammal
A
A
A
A
A
A
Yes
No
Yes
Yes
Yes
No
No
No
No
APPENDIX I
00029963 No
No4
00028712;00028715 No5
00028716
00029972
No
No
No
No
No4
No 4
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRA2
Data Requirement
Composition
Use 2
Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3
§158.135 Toxicology - Continued
CHRONIC TESTING;
83-1 - Chronic Toxicity - TGAI
2 species:
- Rodent, and
- Non-rodent (Dog)
83-2 - Oncogenicity - TGAI
2 species:
- Rat (preferred), and
.«*
"!
- Mouse (preferred)
83-3 - Teratogenicity - TGAI
2 species:
- Rat
- Rabbit
83-4 - Reproduction - Rat TGAI
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI
TGAI
84-2 - Structural Chromosomal
Aberration
84-4 - Other Genotoxic Effects
TGAI
A
A
A
A
Yes
Yes
Yes
Yes
A
A
A
Yes
Yes
Yes
Yes
Yes
Yes
APPENDIX I
-11-
00044585
00044586
No
No
00044485 No
00139552 ,-00111886 No
00029959;00029960 No5
00029961 No
00029962 No
00029459 ,-00029953 No5
00029954;00029955 No5
00029957
i
00029958;GS00234007 No5
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3
§158.135 Toxicology - Continued
SPECIAL TESTING
85-1 - General Metabolism
PAI or PAIRA
Yes
86-1 - Domestic Animal
Safety
Choice
Yes
00028685;00028674 Nob
00028667 ,-00028675
00028668 ,-00028676
00028671;00041503
00028669;00041497
000 28672 ,-00041499
00041500 ,-00041498
00041501 ,-00028682
GS00234006
00041513;00044591 No5
Ln
APPENDIX I
-14-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.135 Toxicology - Continued
1. Composition: PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several
test substances determined on a case-by-case basis.
2. The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aqautic, Food Crop;
D=Aquatic, Non-Fbod; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3. Data must be submitted within the indicated time frame, based on the date of the Guidance Document....
0 12 Month Due Date is .
4. Amitraz is not an organophosphate compound and is not structurally related to a substance that causes delayed
neurotoxicity.
5. All references must be cited to satisfy this data requirement.
APPENDIX I
-15-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
Does EPA Have Must Additional Data
Data To Satisfy "• Be Submitted Under
1 Use 2 This Require- Bibliographic FIFRA § 3(c)(2)(B)?
Data Requirement Composition Pattern ment? Citation Time Frame for Data
Submission 3
§158.140 Reentry Protection
132-1 - Foliar Dissipation TEP A No
132-1 - Soil Dissipation TEP " A No
133-3 - Dermal Exposure TEP A No
133-4 - Inhalation Exposure TEP A No
§158.142 Spray Drift
201-1 - Droplet Size Spectrum TEP A No
201-1 - Drift Field Evaluation TEP A No
Special Testing
|
Yes4 27 Month
No5
i - No5
I
No5
No5
No5
Glove Permeability Study
TEP
No
Yes6 6 Months
1. Composition: TEP = Typical end-use product.
2. The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 6 Month Due Date is .
0 27 Month Due Date is
cn
ON
APPENDIX I
-16-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
158.140 Reentry Protection
158.142 Spray Drift
Special Testing (continued)
4. An interim 24-hour reentry interval is being imposed until the foliar dissipation data are received and reviewed
by the Agency.
5. Not required because the criteria that would trigger these requirements have not been exceeded.
, 6. Because of the oncogenicity potential of amitraz, data are required detailing the permeability and breakthrough
times of materials used in "protective" gloves. Data are required to support liquid amitraz formulations. A
description of this study can be found in ASTM 739-81- Standard Test Method for Resistance of Protective Materials To
Permeation by Hazardous Liquid Chemicals.
APPENDIX I
-17-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
1
Data Requirement Composition
§158. 145
Aquatic
Wildlife and
Organisms
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
Use 2 This Require- Bibliographic FIFRA § 3(c)(2)(B)?
Pattern ment? (Yes, No Citation Time Frame for Data
or Partially) Submission ^
AVIAN AND MAMMALIAN TESTING
71-1 -
71-2 -
71-3 -
71-4 -
71-5 -
en
oo
Acute Avian Oral Toxlclty TGAI
Avian Subacute Dietary
Toxlclty
- Upland Game Bird, and TGAI
U-40481
- Waterfowl TGAI
Wild Marrmal Toxlclty TGAI
Avian Reproduction TGAI
- Upland Game Bird, and
- Waterfowl
Simulated Field Testing TEP
- Mamnals, and
- Birds
Actual Field Testing TEP
- Mamnals, and
- Birds
A
A
A
A
A
A
A
A
A
A
A
Yes
Partial
No
Yes
No
Partial
Partial
No
No
No
No
APPENDIX I
-18-
00030451 No
00030452 Yes1* 9 Months
Reserved5
00030453 No
No
00072412 Yes6 24 Months
00072411 No6 24 Months
Reserved?
Reserved?
Reserved?
Reserved?
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITHAZ
1
Data Requirement Composition
§158.145 Wildlife and
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-1 - Freshwater Pish Toxicity
a. Coldwater Pish Species,
b. Coldwater Pish Species
c. Warmwater Pish Species
d. Warmwater Pish Species
72-2 - Acute Toxicity to
Freshwater Invertebrates
72-3 - Acute Toxicity to
Estuarine and Marine
Organisms
- Fish
- Mollusk
CD
^O - Shrimp
TGAI
TEP
U-40481
TGAI
TEP
TGAI
TEP
U-40481
TGAI
U-40481
TGAI
U-40481
TGAI
U-40481
Does EPA Have
Data To Satisfy
Use 2 This Require- Bibliographic
Pattern ment? Citation
A
A
A
A
A
A
A
A
A
A
A
A
A
A
Yes
Partial
No
Partial
Partial
Yes
No
No
No
No
Yes
No
Yes
No
APPENDIX I
-10-
00030446; 00030445
00030445
00030447; 00030448
00030444
00030447 ;00030448
00030444
GS00234021
-
GS00234022; 00030450
GS00234022; 00030450
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3
No
Yes9
Reserved5
Yes8
No8
No
Yes 10
Reserved5
Yesll
Reserved5
Noll
Reserved5
Noll
Reserved5
9 Months
9 Months
9. Months
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3
§158.145 Wildlife and
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-3 - Acute Toxicity to
Estuarine and Marine
Organisms (continued)
- Fish TEP
- Mollusk TEP
- Shrimp TEP
72-U - Fish Early Life Stage, TGAI
and
- Aquatic Invertebrate
Life-Cycle
72-5 - Fish - Life-Cycle TGAI
72-6 - Aquatic Organism TGAI, PAI OR
A
A
A
A
A
A
A
No
No
No
No
No
No
No
ON
O
Accumulation
- Crustacean
- Fish
- Insect Nymph
- Mollusk
Degradation
Product
72-7 - Simulated Field Testing
- Aquatic Organisms
TEP
No
Noll
Noll
Noll
Yes
Yes
ReservedlS
Reservedl3
15 Months
15 Months
Reservedl2
- Actual Field Testing
TEP
A
• No
APPENDIX I
Reservedl2
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.145 Wildlife and Aquatic Organisms - Continued
1. Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient;
TEP = Typical end-use product; U-40481 = degradation product of amitraz
2. The use patterns are coded as follows: A=Terrestrial, Pood Crop; B=Terrestrial, Non-Pood Crop; C=Aquatic, Pood Crop;
D=Aquatic, Non-Pood; E=Greenhouse, Pood Crop; P=Greenhouse, Non-Food; G=Porestry; H=Domestic Outdoor; I=Indoor.
3. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 9 Month Due Date is '_.
0 12 Month Due Date is .
0 15 Month Due Date is ; .
0 24 Month Due Date is .
4. The Japanese quail Is not a recommended species. A study using the bobwhite quail is required.
5. Available data shows that a degradation product of amitraz (U-40481) is substantially more toxic than the parent.
Testing with this degradation product may be required depending upon requested environmental fate data and the
results of the requested ecological effects studies on amitraz.
6. An NOEL was not established in either the bobwhite or mallard duck study. However, only one avain reproduction
study needs to be repeated, preferably with an upland gamebird (the bobwhite quail is preferred).
7. Reserved pending receipt of requested environmental ,fate data and/or the results of the avian reproduction data.
8. The referenced studies do not fulfill guideline requirements because the harlequin fish and the carp are not
recommended test species. Also, in one study the test containers were lined with polyethylene plastic.
9. This study does not fulfill guideline requirements because it is only a 48-hr study instead of the required
96-hour and the test levels were not measured. This study Is required because the test results suggest that
amitraz in the 20% EC formulation is more toxic to fish than technical amitraz.
10. A 48-hour aquatic invertebrate study with the 20% EC is required because test results suggest that amitraz
in the 20% EC formulation is more toxic to fish than technical amitraz.
11. Marine/estuarlne testing is not required for the pear use. Present data fulfill requirements for oyster and
shrimp, but the estuarine fish study would be required for future uses.
^ APPENDIX I
"""* -21-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.1*15 Wildlife and Aquatic Organisms - Continued
12. Reserved pending the results of requested environmental fate data
13. Reserved pending the results of the early life stage,and aquatic invertebrate life-cycle studies and
requested environmental fate studies.
ON
ro
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
Does EPA Have
Data To Satisfy
1 Use 2 This Require-
Data Requirement Composition Pattern ment?
§158.150
121-1 -
Plant Protection
TARGET AREA EP No
PHYTOTOXICITY
Must Additional Data
Be Submitted Under
Bibliographic PIFRA § 3(c)(2)(B)?
Citation Time Frame for Data
Submission
No3
NONTARGET AREA PHYTOTOXICITY
122-1 -
122-1 -
122-2 -
123-1 -
123-1 -
123-2 -
124-1 -
124-2 -
ON
( >j
TIER I
Seed Germination/ TGAI No
Seedling Emergence
Vegetative Vigor TGAI No
Aquatic Plant Growth TGAI No .
TIER II
Seed Germination/ TGAI No
Seedling Emergence
Vegetative Vigor TGAI No
Aquatic Plant Growth TGAI No
TIER III
Terrestrial Field TEP No
Aquatic Field TEP No
APPENDIX I
-23-
No3
No3
No3
No3
No3
No3
No3
No3
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
§158.150 Plant Protection
(continued)
1. Composition: TGAI = Technical grade of the active Ingredient; TEP = Typical end-use product. EP = End-use product.
2. The use patterns are coded as follows: A=Terrestrial, Pood Crop; B=Terrestrial, Non-Food Crop; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Doraestic Outdoor; I=Indoor.
3. These data are not required in accordance with §158.150.
APPEWDIX I
-24-
-------
TABLE A
GENERIC DATA REQUIREMENTS bX)R CHEMICAL:
AMITliAZ
Data Requirement
1
\
1
Composition
Use 2
Pattern
Does EPA have
Data To Satisfy
This Require-
ment?
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIPRA § 3(c)(2)(B)?
Time Praine for Data
Submission
Nontarget Insect
NQNTARGET INSECT TESTING -
POLLINATORS:
Honey bee acute
contact toxic ity
141-2 - Honey bee - toxicity
of residues on
foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
TGAI
TEP
(Reserved)
TEP
Yes
No
00074486
No
No
No3
No3
ON
LTI
APPENDIX I
-25-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?
Bibliographic
Citation
§158.153 Nontarget Insect - Continued
NQNTARGET INSECT TESTING -
AQUATIC INSECTS:
142-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
TESTING - PREDATORS
thru AND PARASITES
143-3
Must Additional Data
Be Submitted Under
FIPRA § 3(c)(2)(B)?
Time Frame for Data
Submission
(Reserved)
(Reserved)
(Reserved)
(Reserved)
1. Composition: T.XJAE = Technical grade of the active Ingredient; TEP = Typical end-use product.
2. The use patterns are coded as follows: A-Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop:
D=Aqautic, Non-b'ood; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H^Domestic Outdoor; I=Indoor.
3. Due to the low toxicity demonstrated by the honey bee acute toxicity study, no further testing is required.
ON
ON
APPENDIX I
-26-
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL:
AMITRAZ
Guideline Citation and Test Guidelines
Name of Test Substance Status
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure . "
of Ingredients
61-2 - Description of Beginning Materials
and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to Verify
Certified Lirnit
Physical and Chemical Characteristics
63-2 - Color
63-3 - Pliysical State
63-'l - Odor
MP R
MP R
MP R
MP CR
MP R
MP R
MP R
MP R
MP R
Are Data Footnote
Required Number
Yes No
n
[X]
OP
[X]
[X]
[X]
n
n
[X]
[X]
n
n
n
[~] 2
n
[X]
tx]
n
Data Must Be
Submitted Within
Time Frames Listed
Below 1
i '
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
0\
APPENDIX I
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL:
AMITRAZ
Guideline Citation and
Name of Test
Test
Substance
Data Must Be
Guidelines Are Data Footnote ' Submitted Within
Status Required Number Time Frames Listed
Yes No Below 1
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-11 - Oxidizing or Reducing
Action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Misclbility
63-20 - Corrosion Characteristics
Other Requirements:
61- 1
ON
CO
- Submittal of samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
R [X]
CR CX]
CR [X]
CR CX]
R [X]
R [X]
CR [X]
CR [X]
R [X]
CR n
n
n
n
n
n
n
n
n
n
[X]
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL: AMITRAZ
Data Requirement
Composition
Does EPA Have
Data To Satisfy
This Require-
ment?
Bibliographic
Citation
Must Additional Data
Be Submitted under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 2
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dermal Toxicity
- Rabbit
81-3 - Acute Inhalation Toxicity
- Rat
81-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation - Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
MP
MP
MP
MP
MP
MP
Yes
Yes
Yes
NO
No
NO
00041539 No3
00040862 No3
00029963 No3
Yes3
Yes3
Yes3
9 Months
9 Months
9 Months
ON
1. Composition: MP = Manufacturing-use product.
2. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 9 Month Due Date is .
3. Data will support both manufacturing-use products 45639-51 and 129.
APPENDIX I
-29-
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL: AMITRAZ
§158.120 Product Chemistry (Continued)
MP = Manufacturing-use Product; R = Required; CR = Conditionally Required
1. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 6 Month Due Date Is .
0 12 Month Due Date is .
0 15 Month Due Date Is .
2. An upper limit must be provided (and certified) for amitraz in the stabilized 93% technical product. An
upper and lower limit must be provided (and certified) for the intentionally added inert in the stabilized
93% technical produt. Also, upper limits must be provided (and certified) for each impurity >0.1% (w:w)
in the stabilized 93% technical product. Finally, any nitrosamines must be Identified and quantified in
six samples of the 93% stabalized technical; two samples of each must be analyzed shortly after production,
three months after production, and 6 months after production. A method sensitive to 1 ppm of N-nitroso
contaminants must be used. An upper limit must be established and certified for any nitrosamines found
to be present.
O
APPENDIX I
-------
APPENDIX II
LABELING APPENDICES
71
-------
SUMMARY-1
LABEL CONTENTS
40 CPR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in "the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredien
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. it must not be
placed in the body of other text. [40 CFR 162.10(g)]
APPENDIX ii r 72
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10{h)(1)(ii)3
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on-the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A Statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(1)(iii) ]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2 ) ] .
APPENDIX II P" 77
-2-
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii ) ]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified cf
the Agency's classification decision.
APPENDIX II
-3-
?~ 74
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale - states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
APPENDIX II «. .
-4- :" 7 5
-------
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has be'en established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR,__PEST/DIS, and CONT/Dis to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this, notice and submitted
for review.
APPENDIX II
-5-
76
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
Delow child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statement
must be grouped together, preferably
blocked .
Note type size requirements.
Note type size requirements.
APPENDIX II
-------
SUMMARY-7
ITEM
7C
7D
•)!
•a
~^i
CD 7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
\
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
APPENDIX II
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OP REQUIREMENT
All pressurized
products, others
with flash
points under
150 °F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Aqency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED U
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
VO
APPENDIX II
-8-
-------
oo
lO
HAJAJUJ3 IO HUMANS
II OOMMIC ANIMALS)
OANQM
MAJA'nOS
on CKEMCAt
nrwcnoNj row use
• «fc>^fc»i * r«tf»rf to
Bf f N1«Y
(I
STOnAGE AND
DISPOSAL
RESTRICTED USE
PESTICIDE
for rclllt lilt le md vif enlf *>t Cirliritd Ipptlcilgri
or ftriDfll yndtr t*>clr dl'ttl tupinliloA »"d only t»r
(hole ltd co>frcd bf (hf Ctrllftrd Applicator* CtrllM-
Clttfq, ,
PRODUCT
NAME
MOAEDCH1S
t
t
100 00%
t.om
'/ 1114 PRODUCT CON1AM9 1*3 Or PEROAUON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
SIAIIUINf O* fWACICM. IHIATUINI
r SVVAUOWIO:
r MHAi^or=
f OH SUM i—^-
r
Sf E SOC PANCL rOM
MfQ BY
fOWM
IPA
NO —
MO
CONItHIS:
CHOP
cno*
CHOP
CHOP
WAMUMnr StATIUfNf
APPENDIX II
-------
©»
CD i
'>! C
C AMI ION
PHiSCM On C>I(UCM
tunic IO"S fO<» US!
• *nfc **>** k» to
ir~t,l h1 • mmr
n( ( nin> Si *lf "(Ml
SIOHAGf; AMD
PRODUCT
NAME
•ii ni »icni oil nis
IOIM
lOOIKtV
i««s rnomici co»i*»«s ins o* rtniiMtou
KEEP OUT OF REACH OF CHILDREN
CAUTION
rn«ric«t
• «m«i I n ^^ - —
» ON S»li ^r- _ __i-rrr
ion
n» -77, ------- -
rnic*i>n>
/^A m>W S'"' ~~~~~"~ : *~~^j^
^S J, n'»nn'.'«n»ii NO ==^=c ^^^
.- 1<)(J NO Jj ^ \
IH n|fii'
Nil
TT
to
.4©
Cnn*>
COOP
wtnnuitv situ n(Ml
-------
Chapter I—Environmental Protection Agency
§ 162.10
qant obtained the data from anothe
(Identify); applicant copied da*
frbm a publication: applicant obtained
a copy of the data from EPA).
(a) The applicant shall submit Vith
his application a statement that HPA,
in lu evaluation of the properties/effi-
cacyAand safety of the formulated
end-use product, may not consider any
data is supporting the application.
except the following data:
(1) The data the applicant has sub-
mitted tfi EPA under paragraph (b) of
this section:
(2) Other data pertainir/g to the
safety of the product's actwe ingredi-
ents. ratheV than to the safety of the
end-use product: and
(3) Existing tolerances.
regulations, ^exemptions/
clearances issued undes
Food. Drug, and Cosmet,
-------
§ 161.10
(Iv) The product registration
number as prescribed In paragraph (e)
of this section:
(v) The producing establishment
number as prescribed In paragraph (f)
of this section:
(vl) An Ingredient statement as pre-
scribed In paragraph (g) of this sec-
tion:
(vll) Warning or precautionary state-
ments as prescribed In paragraph (h)
of this section:
(vlll) The directions for use as pre-
scribed In paragraph (I) of this section:
and
(Ix) The use classifications) as pre-
scribed In paragraph (J) of this section.
(2) Prominence and legibility. (I) All
words, statements, graphic representa-
tions, designs or other Information re-
quired on the labeling by the Act or
the regulations In this part must be
clearly legible to a person with normal
vision, and must be placed with such
— _ consplcuousness (as compared with
* other words, statements, designs, or
graphic matter on the labeling) and
expressed In such terms as to render It
likely to be read and understood by
the ordinary Individual under custom-
QQ »ry conditions of purchase and use.
. , (II) All required label text must:
^ (A) Be set In « point or larger type:
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be uted. All required
label or labeling text shall appear In
the English language. However, the
Agency may require or the applicant
may propose additional text In other
languages as Is considered necessary to
protect the public. When additional
text In another language Is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label— of the
Act. a pesticide or a device declared
subject to the Act pursuant to
1182.16. la mlsbranded If It* labeling u
false or misleading In any particular
Including both pestlcldal and non-pea-
tlcldal claims. Examples of statements
or representations In the labeling
which constitute mlsbrandlng Include:
(I) A false or misleading statement
concerning the composition of the
product:
(II) A falsa or misleading statement
concerning the effectiveness of the
product M • pesticide or device;
(III) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device;
(Iv) A false or misleading comparison
with other pesticides or devices:
(v) Any statement directly or Indi-
rectly Implying that the pesticide or
device la recommended or endorsed "
any agency of the Federal Govern-
ment;
(vl).The name of a pesticide, which
contains two or more principal active
Ingredients If the name .suggests one
or more but not all such principal
active Ingredients even though the
names of the other Ingredients arc
staled elsewhere In the labeling:
(vll) A true statement used In such a
way as to give a false or misleading Im-
pression to the purchaser:
(vlll) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(Ix) Claims as to the safely of Ihe
pesticide or Its Ingredients. Including
statements such as "safe." "nonpolson-
oiis." "nonlnjurloiis." "harmless" or
"nonloxlc lo humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/nr compara-
tive statements on the safely of the
product. Including but not limited to:
(A) "Contains all natural Ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(8) Final printed labeling. (I) Except
as provided In paragraph (a)(6)(ll> of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(II) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product Is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(I) Is false or misleading, or
(II) Has not been approved by the
Administrator through registration or
supplemental registration as an addl-
ii 1 --m.«|. pursuant lo { 182 fl.
$ 167.10
(c) Name and address of producer.
registrant, or person for whom pro-
dured. An unqualified name and ad-
dress given on the lahel shall he ran
sldrred H.I the name and addre.w of thr
producer. If thr registrant's name ap-
pears on the label and the registrant Is
not the producer, or If I he name nf (he
person for whom the pesticide was
produced appears on (he label. II must
be qualified by appropriate wording
such as "Packed for • * V ' ntslrlbul
ed by * * *." or "Sold by • * •" to show
that Ihe name Is not Hint of the pro-
ducer.
(d) Net weight or measure nf con-
tend. (1) The net weight or measure
of content shall be exclusive nf wrap
pers or other materials and shall be
the average content unless explicitly
slated as a minimum quantity.
(2> If the pesticide Is a liquid. Ihe
net content statement, shall be In
terms of liquid measure at. <18" F (20T)
and shall be expressed In conventional
American units of fluid ounces, pints.
quarts, and gallons.
(3) If the pesticide Is solid or semlso
lid. viscous or pressurized, or Is a mix-
ture of liquid and solid, the net con-
tent statement shall be In terms nf
weight expressed as avoirdupois
pounds and ounces.
M) In all cases, net content shall he
staled In terms of the. largest suitable
units. I.e.. "I pound 10 ounces" rather
than "26 ounces."
(8) In addition to the required units
specified, net content may be ex-
pressed In metric units.
(0) Variation above minimum con-
tent or around an average Is permissi-
ble only to the exte.nt that It repre-
sents deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum Is not permit-
ted. In no case shall the average con-
tent of the packages In a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time nf
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.." or the phrase "EPA Reg.
No." The registration number shall be
set In type of a size and style similar to
other print on that part of (he label
on which It Appears and shall run par
-------
CO
9 162.10
•Del to It. The registration number
and the required Identifying phrase
shall not appear In such a manner M
to suggest or Imply recommendation
or endorsement of the product by the
Agency.
(I) Producing establishment* regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phraae "EPA Rst.". of the
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
package If the EPA establishment reg-
istration number on the Immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(1) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active Ingredient, the total per-
centage by weight of all Inert Ingredi-
ents: and If the pesticide contains ar-
senic In any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active Ingredients must be
designated by the term "active Ingredi-
ents" and the Inert Ingredients by the
term "Inert Ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be In the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" Is
not required for pesticides which con-
lain 100 percent active Ingredients.
Unless the Ingredient statement Is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement.
(2) Position of Ingredient statement.
(I) The Ingredient statement Is nor-
mally required on the front panel of
the label. If there Is an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read, the Ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes It Impracticable to
place the Ingredient statement on the
front panel of the label, permission
may be granted for the Ingredient
statement to appear elsewhere.
Till* 40—Protection of Environment
(II) The text of the Ingredient state-
ment must run parallel with other
text on the panel on which It appears.
and must be clearly distinguishable
from and must not be placed In the
body of other text.
(3) Namei to be used In \ngrtilieni
statement The name used for each In-
gredient shall be the accepted
common name. If there Is one. fol-
lowed by the chemical name. The
common name may be used alone only
If It Is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(cM8).
M) Statements of percentage*. The
percentages of Ingredients shall be
slated In terms of welght-to-welghl.
The sum of percentages of Ihe active
and Ihe Inert Ingredients shall be 100.
Percentages shall nol be expressed by
a range of values such as ">2-2ft%.' If
Ihe uses of Ihe pesticide product are
expressed as weight of active Ingredi-
ent per unit area, a statement of the
weight of active Ingredient per unit
volume of the pesticide formulation
shall also appear In the Ingredient
statement.
(6) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting Rood manu-
facturing practice. It there may be un-
avoidable variation between manufac-
turing batches, the value staled for
each active Ingredient shall be the
lowest percentage which may be pres-
ent.
(6) Deterioration. Pesticides which
change In chemical composition sig-
nificantly must meet the following la-
beling requirements:
(I) In cases where It Is determined
thai a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement In a prominent position on
the label: "Not for sale or use after
(date]."
(II) The product must meet alt label
claims up to the expiration time Indl-
calrd on the label.
(1) Inert Ingredients. The Adminis-
trator may require the name of any
Chapter I—Environmental Protection Agency
$ 169.10
Inert Ingredlent(s) lo bo listed In the
Ingredient statement If he determines
tha.t such Ingredlcnf(s) mny pose a
hazard to man or the environment
(h) Warnings and precautionary
statement* Required warnings ' and
precautionary statement* concerning
the general areas of tnxlrologlral
hazard Including hazard to children.
environmental hazard, nnd physical or
chemical hazard fall Into two groups;
those required on the front panel of
the labeling and those which may
Hiivd Mnton
o>mto_
DMfiMl ID...
appear elsewhere Specific require
menls concerning content, placement.
type size, and prominence are elven
below.
II) nfquired front panel itatrmenti.
With Ihe exception of Ihe child
hazard warning statement, the text re
quired on the front panel of Ihe label
Is determined by Hie Toxlrlly Calego
ry of the pesticide The category Is as-
signed on the basli of Hie highest
hazard shown by anv of Ihe Indicators
In the table below
to>V«y <
lip U ind hrkirtng VI
mg/lg
Up In «"d lnrk«*<9 7
mQIUm
lip to and fc-n kn»^j ?no
mo/kg
riom VI K«u VKI fnp/hq
riom 7 Kwu ? fng/lt«*
From TOO ttvu 7000
S«v«f» MtuHon d r?
how
rtofn VM1 Itwil VyVt fnq'
kg
From T ttwu TO mg'M«>
From 7.000 Ihni TO OOO
f~ii»a)t^* t\an 11 «riQ/M
f>*Ht*o ihun 70 nnn
Mlbf tv "»qM trrtlNtWwt •!
(I) Human hazard signal word—(A)
Toiicitv Catenary I. All prsllelde prod-
ucts meeting the criteria of Toxlclty
Category I shall bear on, the front
panel the signal word "Danger." In ad-
dition If thr product was assigned lo
Toxlclty Category I on the basis of Its
oral. Inhalation or dermal toxlclty (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
In red on a background of distinctly
contrasting color and the skull and
crossbones shall appear In Immediate
proximity to the word "poison."
(B) Toiicitv Category //. All pesti-
cide products meeting the criteria of
Toxlclty Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toiicitv Category III. All pesti-
cide products meeting the criteria of
Toxlclty Category HI shall bear on
the front panel the signal word "Cau-
tion."
(D) Toj-irifv Category IV. All pesll-
clde products meeting the criteria of
Toxlclty Category IV shall bear on the
front panel Ihe signal word "Caution."
if.} Vse of signal words. Use of any
signal word(s) associated with a higher
Toxlclty Category Is not. permitted
except when the Agency determines
that such labeling Is necessary to pre
vent unreasonable adverse effect* on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(II) Child hazard warning Fvery pes
tlclde product label shall bear on the
front panel the statement "keep out of
reach of children." Only In rases
where the likelihood of contact with
Children during distribution, market-
ing, storage or use Is demonstrated by
the applicant to be extremely remote.
or If the nature of Ihe pesticide Is such
that. It Is approved for use on Infants
or small children, may Ihe Administra-
tor waive this requirement.
(Ill) Statement of practical treat
ment—(A) Toiicitv Category I. A
•tatement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall
Ing Into Toxlclty Category I on Ihe
basis of oral. Inhalation or dermal ton
Icily. The Agency may. however.
permit reasonable variations In Ihe
placement of the statement of practl
APPENDIX II
-13-
-------
CO
S 1*1.10
cat treatment li some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toiicitv cateyoriti. The
statement of practical treatment Is not
required on the front panel except as
described In paragraph (h XI Hill MA) of
this section. The applicant may. how-
ever. Include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label In
accord with paragraph (h)(2> of this
section If they do not appear on the
front panel.
(Iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Till* 40—Protection of f nvlronmont
Chapter I—Environmental Protection Agency
§147.10
9 and undv
Abovo 5 to 10. .
Abova 10 to II..
Abov* IS to 30 .
Ovo 30
wwd. •!
cot**
10
II
(J) Other required warntngi and pre-
cautionary itatementt. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary' Statements" and
under appropriate subheadings of
"Hazard to Humana and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(I) Hazard (o human* and domeitlc
animal*. (A) Where a hazard exist* in
humans or domestic animals, precau-
tionary statements are required Indi-
cating the particular hazard, the
routeXs) of exposure and the precau-
tions to be Uken to avoid accident.
Injury or damage. The precautionary
paragraph shall be Immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typl- j
cat precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Oral. Hnt««un. o> dvm* k»fc*r
ft/Of (poVHKM) I „„
trough «knl Do no tn*t» mx> Idurt <* opr»f
Moll. Do nol got h •(«. en pUn, a on etoMng
bo to* I l*iloi.ad _
i lUn) Do nol braatw vapor* IduM of
I Oo not (al to avaa, on aUn. or on
doCong IAtJt.un.lala *ral oK alaramanM tao^rx) |.
larmtui I a«a»0f»ad Invalid Of abaorbad avnugh Ka
aktil Avoid baa«*«j »vxn (dual or aria, mMI
Anld oonUd wth t*«i lar*t Of doNngl lAppro-
SMi and »r» toe* •«•<»
Do flol got frl ayoa. on akin, or on
, WMI aog^M or taoo oHrtt and iuhi»
lAcpro
r»ail •)• |*nd «Un| MWtan. Do not •>! kl •««*.
on iUn, or on cfc**» HorniM I »»»»u~»«l !««•
prapWo fc* Xd iMonoiil r^n*»l I
(Mo,
(II) Environmental hazardi. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the nporoprliite prerau-
Injury or damage. Examples of the
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide Intended for out-
door line conlnlna an Motive
100 or less, the statement "This Pesti-
cide Is Toxic to Wildlife" Is required.
(B) If a pesticide Intended for out-
door use contains an active Ingredient
with a fish acute I.C.. of 1 ppm or less;
the statement "This Pesticide Is Toxic
to Fish" Is required.
(C) If a pesticide Intended for out-
door use contains an active Ingredient
with an avlnn acute oral LI)., of 100
mg/kg or less, or a suharute dietary
LC» of 500 ppm or less, the statement
"This Pesllrldo Is Toxic to Wildlife" Is
required.
If either accident history or field
studies demonstrate that use of the
pesticide may result In f (Unlit y to
birds, llsh or mammals, the statement
"This pesticide Is extremely toxic to
wildlife (fish)" Is required.
(R) For uses Involving foliar applica-
tion to agricultural crops, forest*, or
shade trees, or for monqullo abate-
ment treatments, pesticides toxlr lo
pollinating Inserts must bear' approprl
ale label cautions.
(F) For nil outdoor uses other thnn
aquatic applications the label must
bear the raullon "Keep out of lakes.
ponds or streams. f)n not contaminate
water by cleaning nf equipment or dls
posal of wastes."
(Ill) rhvtical or rhrmical hnrnrii*
Warning statements on the flammahll
My or explosive characteristics of the
pesticide are required as follows
Hatfi poM H or brknf W F. • n»a K a
•Of vahra OfjaiOig
FknH poW abma 70' F and nd ovar an' F or « IK
Rama avlamlon H mora vhan in in long al a riKlanca
ol A hi horn Ina flarna
Al olhar pra4*«t!*fi M»«T Imm
Cn rml |MVWti«* n. lnrBi«.*ia
'•^ Ahnvw im* f mMV ratn*
burinng
Flatnmabht Contarrli unrlar fjnp|«ra KvMft awav l>nm twal
aparht. and opan Rama Dv> nol frtfnrriiaa or hnrfrM*ato rtm*«»nfl.
Enpoaiifa In tampwahva* obova im* F mav eair*a Up^nng
Cordarrit turlar rjfatvi^a Oo nol lrw or «tofa naar IMMI or nrMn
Rama Oo nol punctm or rnrlna.«la ctmlatMi F.pm>«« lo
ilw« ahov* 130* F may r^i
4B) NONrMfStumrtD COHTAM*mt
Al Of t»km XT F
Aboo* JO' F and not OM> XT F
Abort «>• F and nol nvaf ISO* F
Do nol UM Of tlof* rM«f hwil Of nrMn flam*
(I) Dfreciionj /or (/*«—(!) General
requirementi—lH Adequacy and clar-
ity of direction*. Directions for use
must be staled In terms which can be
easily read and understood by the
average person likely to use or to su-
pervise the use of the pesticide. When
followed, directions must be adequate
to protect the public from fraud and
from personal Injury and to prevent
unreasonable adverae effects on the
environment.
(II) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
(A) If required by the Agency, such
printed or graphic matter Is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag:
(D) The label bears a reference lo
the directions for use In accompanying
leaflets or circulars, such as "See di-
rections In the enclosed circular'" and
(C) The Administrator determines
that It Is nol necessary for such direr
tlons to appear on the label.
(Ill) Exceptions to requirement /or
direction for use—(A» Detailed dlrec
tlons for uoe may be omltled from la
bellng of pesticides which are Inlende.d
for use only by manufacturers ol prod-
ucts other than pesticide products In
their regular mftniifactnrlnB processes
-------
{ 161.10
(/) The label clearly shows that the
product Is Intended (or use only In
manufacturing processes and specifies
the lypHs) of products Involved.
(2) Adequate Information such as
technical data sheets or bulletins. Is
available to the trade speclfylni the
type of product Involved and Its
proper use In manufacturing process-
es;
(J) The product will not come Into
the hands of the general public except
•fter Incorporation Into finished prod-
ucts; and
(4) -The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale Is limited
to physicians, veterinarians, or drug-
flats, provided that:
(I) The label clearly states that the
product Is for use only by physicians
or veterinarians:
<2> The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
feels on man or the environment; and
(J) The product Is also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
associated
with each site.
(v) The dorage rate associated with
each site and pest.
(vl) The method of application. In-
cluding Instructions for dilution. If re-
quired, and type(s) of application ap-
paratus or equipment required.
(vll) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
advene effects on the environment.
(vlll) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(Ix) Specific directions concerning
the storage and disposal of the pesti-
cide and Its container, meeting the re-
quirement* of 40 CFR Part 106. These
Instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
•el In type of the same minimum sices
as required for the child hazard warn-
ing (See Table In I !«7.1(MhMlMlv).)
(x) Any limitations or restriction on
use required to prevent unreasonable
advene effects, such as:
(A) Required Interval* between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
In or adjacent to certain areas.
(D) (Reserved)
(E> For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who Is not phys-
ically present at the site of application
Chapter I—Environmental Protection Agency
but nonetheless available to the
person .applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who Is physically present. '
(F) Other pertinent Information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(J) Statrmrnt of tlur Classification.
By October 22. 1916. all pesticide prod
nets must bear on their labels a state-
ment of use classification ax described
In paragraphs (JKIl anrt (2) of this sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth In this sub-
section, and shall be marketed as sepa-
rate products with different registra-
tion numbers, one hearing directions
only for general use(s) and the other
hearing directions for restricted use(s)
except that. If a product tins both re-
stricted use(s) and general used), both
of these uses may appear on a product
labeled for restricted use. Such prod
iicta shall be subject to the provisions
of | I62.IO(JM2>.
(I) General Use C7iu.il/lraMon. Pesti-
cide products bearing directions for
use(s> classified general shall be la-
beled with the exact words "General
Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained In the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of mlsbrandlng.
(2) Restricted Vtt Cliust/lcoffon.
Pesticide products bearing direction
for iwe(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(II Front panel statement of restrict-
ed use classification. (A) At the lop of
the front panel of the label, set In type
of the same minimum sizes as required
• for human hazard signal words (see
table In | I62.10(h)(l >(lv». and appear-
ing with sufficient prominence relative
lo other text nnd graphic material on
§i*rn
the front panel to make It unlikely lo
be overlooked under customary con«ll
lions of purchase nnd use, Ihe slale-
menl "Reslrlcted Use Pesticide" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction Imposed a.*
• precondition lo registration shall
appear. If use Is restricted to certified
applicators, the following statement Is
required: "For retail sale to and use
only by Certified Applicators or per
sons under their direct supervision and
only for those uses covered by the Cer
llfled Applicator's certification." If.
however, other regulatory restrictions
are Imposed, the Administrator will
define the appropriate wording for Ihe
terms of restriction by regulation.
(k) Advertising. (Fit-servedI •
140 FR 2828(1. July 1. 1975: 40 FTt 3JM9.
Aim. 1. 1975: 40 PR 3«S7I. Aim 21. 197V »
•ntrnrirct Rl 43 FR S7HS. Frb 9. 197)11
ll«Z.tl Crltrrla tat itrlrrmlni>llnn« of ut|
reasonable •dwrrsr riTrrln.
(B.) Criteria for Issuance of Notlof at
IntSut to Deny Registration. rJncel
Realisation, or to Hold a llra/ina -
(I) Presumption. (I) A rebuttaUte pre-
sumption shall arise that a trollce of
Intent loVleny registration pursuant lo
section 3ft:H«) of the Act./notice of
Intent to cancel registration pursuant
to section VbXI) of tht Ael. or n
notice of IntVnl lo hold'a hearing to
determine wntlher t-tfe registration
should be canceled or denied, as ap-
propriate, shall \>e bhiied, upon a de-
termination by trreXdmlnlslrator thai
Ihe pesticide meeUf or exceeds any of
the criteria for rJskViet forth In para-
graph (a)(3) of tnls sVllon. Upon such
determination-/ the\ Administrator
shall Issue notice by certified mall lo
the applicant or registrant, as the case
may be. aiming that theVappllrant or
registrant/ has the opportunity to
submit evidence In rebutlM of such
presumption In accordance wJth para
graph/a)M) of this section, llie appli-
cant OT registrant shall have forty-five
s frorn the dale such notice Is
sen to submit evidence In rebuttal of
the presumption; provided, however.
at for good cause shown the AdnNn-
fstralor may grant an additional slul
APPENDIX II
-15-
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dernval toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label- instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal"statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
APPENDIX II
-16-
87
-------
PEST/DIS-2
PESTICIDE ACTIVE INGREDIENTS THAT ARE ACUTE HAZARDOUS WASTES
PESTICIDES ON THE "E" LIST (with RCRA # and CAS f
[40 CFR 261.33(e)]
Acrole in
Aid icarb
Aldr in
Allyl alcohol
Aluminum phosphide
4-Aminopyridine (Avitrol)
Arsenic acid
Arsenic pentoxide
Arsenic•trioxide
Calcium cyanide
Carbon disul£ide
p-Chloroaniline
Cyanides (soluble cyanide salts
not otherwise specified)
Cyanogen chloride
Die Idrin
0,0-Diethyl S-[2-ethy1thio)ethyl]
phosphorodithioate (disulfoton)
0,O-Diethyl O-pyrazinyl
phosphorothioate (Zinophos®)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl
phosphorothioate (methyl parathipn)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexachlorohexahydro-exo,exo-
dimothanonaphthalene (Isodrin)
Hydrocyanic acid
Methornyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide
(OMPA, schradan)
Parathion
Phenylinercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium f luoroacetat,e
P003 107-13-1
P070 116-06-3
P004 309-00-2
POOS 107-18-6
P006 1302-45-0
POOS 504-24-5
P010 7778-39-4-.-
P011 1303-28-2
P012 1327-53-3
P021 592-01-8
P022 75-15-0
P024 106-47-8
P030
P031 506-77-4
P037 60-57-1
P039 298-04-4
P040 297-97-2
P044
P071
P047
P034
P020
P050
P088
P051
P097
P057
P059
P069
P063
P066
P072
P075
P085
P089
P092
P094
P098
P102
P105
P106
P058
60-51-5
298-00-0
534-52-1
131-89-5
88-85-7
115-29-7
129-67-9
72-20-8
52-85-7
640-19-7
76-48-8
465-73-6.
74-90-8
16752-77-5
86-88-41
54-11-5
152-16-9
56-38-2
62-38-4
298-02-2
151-50-8
107-19-7
26628-22-8
143-33-9
62-74-8
APPENDIX II
-17-
-------
PEST/DIS-3
Strychnine and salts P108
O,O,O,O-Tetraethyl P109
dithiopyrophosphate (sultotepp)
Tetraethyl pyrophosphate Pill
Thallium sultate P115
Thiofanox P045
Toxaphene P123
Warfarin(>0.3%) POOL
Zinc phosphide (>10%) P122
57-24-9
60-41-3
3689-24-5
107-49-3
7446-18-6
39196-18-4
8001-35-2
81-81-2
1314-84-7
50 ACTIVES
II. PESTICIDES DERIVED FROM TRI-, TETRA-,
[40 CFR 261.31]
2-Chloroethyl 2-(2,4,6-trichloro- F027
phenoxy) ethyl ether
Dehydroabietylammonium F027
pentachlorophenoxide
Erbon F027
0-ethyl 0-(2,4,5-trichlorophenyl)
ethylphosphonothioate F027
2,2'-Methylenebis F027
(3,4,6-trichlorophenol)
(Hexachlorophene)
--Potassium salt of F027
—Sodium salt of F027
—Disodium salt of F027
Pentachlorophenol F027
—Potassium salt of F027
—Sodium salt of F027
.—Zinc salt of F027
'—Zinc salt of -N-alkyl F027
^C16~C18)~1/3-propanediamine
—Pentachlorophenyl laurate F027
Potassium trichlorophenate (2,4,6) F027
Potassium trichlorophenate (2,4,5) F027
Silvex F027
—2-Butoxyethyl ester F027
--Butoxypolypropoxypropy1 ester F027
—Butoxypropyl ester F027
—Diethanolamine salt F027
—Diisopropanolamine salt F027
—Dimethylamine salt F027
—Dipropylene glycol isobutyl F027
ether ester
--Ethanolamine salt F027
—2-Ethylhexyl ester F027
--Isooctyl ester F027
AND PENTACHLOROPHENOLS
5324-22-1
35109-57-0
136-25-4
327-98-0
70-30-4
67923-62-0
3247-34-5
5736-15-2
87-86-5
7778-73-6
131-52-2
2917-32-0
3772-94-9
2591-21-1
35471-43-3
93-72-1
19398-13-1
53404-07-2
25537-26-2
51170-59-3
53404-09-4
55617-85-1
53535-26-5
7374-47-2
53404-76-5
53404-14-1
APPENDIX II
-18-
89
-------
PEST/DIS-4
—Isopropanolamine salt
--Monohydroxylaluminum salt
—Polypropoxypropyl ester
--Potassium salt
--Propylene glycol isobutyl
ether ester
--Sodium salt
--Triethanolamine salt
--Triethylamine salt
--Triisopropanolamine salt
--Tripropylene glycol isobutyl
ether ester
Sodium 2-(2,4,5-trichlorophenoxy)
ethy 1 sulfate
Tetrachlorophenols
--Alkylamine*amine salt (as in
fatty acids of
—Potassium salt
--Sodium salt
coconut oil
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenol salt of
2 , 6-bis[(dimethylamino)methy1]
cyclohexanone
2 , 4 , 5-Trichlorophenol, sodium salt
2,4,6-Trichlorophenol, sodium salt
2,4,5-Trichlorophenoxyacetic acid
--Alkyl C-12 amine salt
--Alkyl C-13 amine salt
--Alkyl C-14 amine_ salt
--N ,N-diethylethanolamine salt
—Dimethylamine salt
--N,N-dimethyllinoleylamine salt
—N ,N-dimethyloleylamine salt
--N-oleyl-1,3-propylene
diamine salt
—Sodium salt
—Triethanolamine salt
--Triethylamine salt
--Alkyl (C3H7 - C7H9) ester
--Amyl ester
--Butoxyethoxypropy1 ester
--2-Butoxyethy1 ester
--Butoxypropy1 ester
--Butyl ester
--Dipropylene glycol isobutyl
ether ester
—2-Ethylhexyl ester
--Isobutyl ester?
F027 53404-13-0
F027 69622-82-8
F027 83562-66-7
F027 2818-16-8
F027 53466-84-5
F027 37913-89-6
F027 17369-89-0
F027 53404-74-3
F027 53404-75-4
F027 53535-30.-1
F027 3570-61-4
F027 25167-83-3
F027
F027 53535-27-6
F027 25567-55-9
F027 95-95-4
F027 88-06-2
F027 53404-83-4
F027 136-32-3
F027 3784-03-0
F027 93-79-8
F027 53404-84-5
F027 53404-85-6
F027 53535-37-8
F027 53404-86-7
F027 6369-97-7
F027 53404-88-9
F027 53'404-89-0
F027 53404-87-8
F027 13560-99-1
F027 3813-14-7
F027 2008-46-0
F027
F027 120-39-8
F027 1928-58-1
F027 2545-59-7
F027 1928-48-9
F027 93-79-8
F027 53535-31-2
F027 1928-47-8
F027 4938-72-1
APPENDIX II
-19-
90
-------
PEST/DIS-5
—Isopropyl ester F027
—Propylene glycol isobutyl F027
ether ester
--Tripropylene glycol isobutyl F027
ether ester
4-(2,4 , 5-Trichlorophenoxy)butyric F027
acid [2,4,5-TB]
2-(2,4,5-Trichlorophenoxy)ethyl F027
hydrogen sulfate [2,4,5-TES]
1,4' , 5'-Trichloro-2'-(2,4,5- F027
trichlorophenoxy)
methanesulfonanilide [Edolan U]
93-78-7
53466-86-7
53535-32-3
93-80-1
69633-04-1
69462-14-2
APPENDIX II
-20-
91
-------
PEST/DIS-6
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE
LIST
(with RCRA #, and CAS
[40 CFR 261.33(f)]
Acetone
Acrylon itrile *
Ami trole
Benzene*
Bis(2-ethylhexyl)phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
.(chloroacetaldehyde )
Chlordane, technical*
Chlorobenzene*
4-Chloro-m-cresol
Chloroform*
o-Chlorophenol
Creosote
Cresylic acid (cresols)*
Cyclohexane
Cyclohexanone
Decachlorooctahydro-1,3,4-metheno-
2H-cyclobuta[c,d]-pentalen-2-one
(Kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-2,3-(Dichloroallyl diisopropyl-
thiocarbamate) (diallate,Avadex)
o-DiChlorobenzene*
p-Dichlorobenzene*
Dichlorod iflupromethane
(Freon 12®)
3,5-Dichloro-N-(l,l-dimethyl-2-
propynyl) benzamide
(pronamide, Kerb®)
Dichloro diphenyl dichloroethane
(DDD)
Dichloro diphenyl trichloroethane
(DDT)
Dichloroethyl ether
2,4-Dichlorophenoxyacetic,
salts and esters (2,4-D)*
1,2-Dichloropropane
1,3-Dichloropropene (Telone)
Dimethyl phthalate
Epichlorohydrin
(l-chloro-2,3-epoxypropane)
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate
(chlorobenzilate)
U002
U009
U011
U019
U028
U136
U211
U034
U036
U037
U039
U044
U048
U051
U052
U056
U057
U142
67-64-1
107-13-1
61-82-5
71-43-2
117-81-7
75-60-5
56-23-5
302-17-0
57-74-9
108-90-7
59-50-7
67-66-3
95-57-8
8021-39-4
1319-77-3
110-82-7
108-94-1
143-50-0
U066
U069
U062
U070
U072
U075
96-12-8
84-74-2
2303-16
95-50-1
106-46-7
75-71-8
-4
U192
U060
U061
U025
U240
U083
U084
U102
U041
U112
U038
23950-58-5
72-54-8
50-29-3
1191-17-9
94-75-7
8003-19-8
542-75-6
131-11-3
106-89-8
141-78-6
510-15-6
*Proposed tor deletion by TCLP proposal
APPENDIX II
-21-
92
-------
PEST/DIS-7
Ethylene dibromide (EDB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfura 1
Hexachlorobenzene*
Hexachlorocyclopentadiene
Hexachloroethane*
HydroEluoric acid
Isobutyl alcohol*.
Lead acetate
Lindane*
Maleic hydrazide
Mer.qury
Methoxychlor *
Methyl alcohol (methanol)
Methyl bromide
Methyl chloride
2,2 '-Methylenebis
(3,4, 6-trichlorophenol)
(hexachlorophene)
[acute waste per 261.31]
Methylene chloride*
Methyl ethyl ketone*
4-Methyl-2-pentanone
(methyl isobutyl ketone)
Naphthalene
Nitrobenzene*
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentachlorophenol*
[acute waste per 261.31]
Phenol *
Pyridine*
Resorcinol
Safrole
Selenium disulfide
Silvex [acute waste per 261.31]
1,1,2,2-Tetrachloroethane*
Tetrachloroethylene*
2,3,4,6-Tetrachlorophenol*
[acute waste per 261.31]
Thiram
Toluene*
1,1, 1-Trichloroethane*
(methyl chloroform)
Trichloroethylene*
Trichloromonofluoromethane
(Freon 11«)
2,4,5-Trichlorophenol*
[acute waste per 261.31]
2,4,6-Trichlorophenol*
[acute waste per 261.31]
U067
U077
U115
U122
U125
U127
U130
U131
U134
U140
U144
U129
U148
U151
U247
U154
U029
U045
U132
106-93-4
107-06-2
75-21-8
50-00-0
98-01-1
118-74-1
77-47-4
67-72-1
7664-39-3
78-83-1
301-04-2
58-89-9
123-33-1
7439-97-6
72-43-5
67-56-1
74-83-9
74-87-3
70-30-4
U080
U159
U161
U165
U169
U170
U184
U185
U242
U188
U196
U201
U203
U205
U233
U209
U210
U212
U244
U220
U226
U228
U121
U230
U231
75-09-2
78-93-3
108-10-1
91-20-3
98-95-3
100-02-7
76-01-7
82-68-8
87-86-5
108-95-2
110-86-1
108-46-3
94-59-7
7488-56-4
93-72-1
79-34-5
127-18-4
137-26-8
108-88-3
71-55-6
79-01-6
75-69-4
95-95-4
88-06-2
APPENDIX II
-22-
93
-------
PEST/DIS-8
2,4,5-Trichlorophenoxyacetic acid U232 93-76-5
(2,4,5-T)*
(acute waste per 261.31]
Wartarin «0.3%) U248 81-81-2
Xyleno U239 1330-20-7
Zinc phosphide «10%) U249 1314-84-7
83 ACTIVES
APPENDIX II
94
-------
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
APPENDIX II
-24-
95
-------
STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES'
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading_STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
.Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or.media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage-, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and.measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occur
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
APPENDIX II
-25- 9 6
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1- Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, iars)
Non-aerosol products
(baqs)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discardinc in trash
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal
based on container type, listed below:
instruction
Container Type Statement
Metal
containers
( non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or punctur
and dispose of in a sanitary landfill, or b
other procedures approved by state and loca
authorities.
Triple rinse (or equivalent). Then offer
for recycling or 'reconditioning, or punctur
and dispose of in a sanitary 'landfill , or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue "into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reusedl, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wordinq)
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
APPENDIX II
-26-
97
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact
wording that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or
feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products _that contain active ingredients
that are Acute Hazardous Wastes or are assigned to Toxicity
Category I on the basis of oral or dermal toxicity, or
Toxicity Category I or II on the basis of acute inhalation
toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that
are Toxic Hazardous Wastes or meet any of the criteria in
40 CFR 261, Subpart C for a hazardous waste must bear the
following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these -wastes cannot be disposed of by
use according to label instructions, centact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be disposec
of on site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the foliowir
disposal statement: "Securely wrap original container in sevc
layers of newspaper and discard in trash."
APPENDIX II Q Q
-27- '
-------
APPENDIX III
USE INDEX APPENDIX
•-* 99
-------
EPA Compendium of Acceptable Uses
106201 AMITRAZ*
TYPE PESTICIDE; Insecticide, Acaricide
FORMULATIONS:
Tech (93%)
WP (50%)
EC (1.5 Ib/gal)
GENERAL WARNINGS AND LIMITATIONS: RESTRICTED USE PESTICIDE. Do not re-
enter treated areas until 24 hours after application unless protective
clothing is worn. Do not tank mix with bordeaux mixtures, detergents,
dodine, ferbam, 1-napthaleneacetic acid (NAA), sulfur, or other highly
alkaline materials. During mixing/loading or application wear a protec-
tive suit which has long sleeves and long pants. Wear chemical resistant
gloves; a hat, boots, and goggles or face shield. A helmet with visor may
be substituted for the hat and goggles during aerial application. Mixer/
loaders should also wear a chemical resistant apron when handling the con-
centrated product. Instead of clothing and equipment specified above, the
applicator can use an enclosed tractor cab or cockpit with properly fil-
tered air supply. Amitraz is toxic to fish. Do not apply directly to
water. Drift and runoff from treated areas may be hazardous to fish in
adjacent sites. Do not contaminate water by cleaning of equipment or
disposal of wastes.
Beneficial Insect Caution;
Amitraz is toxic to predacious mites such as Typhlodromus accidentalis,
Amblyseius fallacis. and stigmaeid mites.
Agricultural Crop Tolerances;
Apples - 0 ppm
Livestock Tolerances;
0 ppm (meat, fat, and meat byproducts of cattle, goats, hogs, horses, and
sheep)
Definition of Terms;
Claims for pest control limited to suppression of population are indicated
by parenthesized pest name.
*N'-(2,4-dimethylphenyl)-N-[[(2,4-dimethylphenyl) imino] methyl]-N-methyl-
methanimidamide
Issued: 10-01-81
Provisional Update: 8-06-85 i QQ
APPENDIX III
-1-
-------
04003AA
Site and Pest
Pear
EPA Compendium of Acceptable Uses
AMITRAZ
Dosages and Tolerance, Use, Limitations
Formulatio"n(s)
3 ppm
7 day preharvest interval through
1.5 pounds per acre for foliar ap-
plication. Do not apply more than
10.5 pounds per acre during the
growing season.
Do not allow livestock to graze
treated areas. Do not apply emulsi-
fiable concentrate formulation as a
summer spray west of the Rocky Moun-
tains when cool, moist, poor drying
conditions exist or when night tem-
peratures are below the dew point,
as fruit injury may result.
.LAVASA
1BGAZA
.LAVAYA
IAVBEA
European red mite
(Codling moth)
(McDaniel spider
mite)
(Twospotted spider
mite)
RAXALA
.IBGAZA
.LAVAYA
:LAVBEA
Pear psylla
(Codling moth)
(McDaniel spider
mite)
(Twospotted spider
mite)
0.75-0.94
Ib/A
[400 gal/A]
[concen-
trate spray]
or
0.188-0.234
lb/100 gal
(1.5 Ib/gal
EC)
0.75-1.5 Ib/A
[400 gal/A]
[concen-
trate spray]
or
3-6 oz/100
gal [0.75-
1.5 Ib/A]
(50% WP)
(1.5 Ib/gal
EC)
Prebloom and foliar applications.
Apply when the majority of overwin-
tering European red mite eggs have
hatched and repeat as needed.
Prebloom application. Application
must occur during a precise point in
the pest's life cycle. Apply after
eggs have moved into the female pear
psyllas oviduct, but prior to heavy
egg laying. Apply when daily maxi-
mum temperatures exceed 50 F (10.0
C). If weather or orchard condi-
tions do not permit treatment before
heavy egg laying, apply after the
majority of the first generation
eggs have hatched. Consult local
Cooperative Agricultural Extension
Service for more specific timing
information. May be tank mixed with
dormant oil.
Foliar application. Apply when ma-
jority of pests are in the adult or
young nymphal stages of development.
Issued: 10-01-81
APPEMDIX III
-2-
10
-------
EPA Compendium of Acceptable Uses
AMITRAZ
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
Pear (continued)
LAJAOA Pear rust mite 0.75-1.5 Prebloom and foliar applications.
TBGAZA (Codling moth) lb/A Apply when the mites become active
LAVAYA (McDaniel spider [400 gal/A] in the spring and repeat as needed.
mite) [concen-
LAVBEA (Twospotted spider trate spray]
mite) or
0.188-0.375
lb/100 gal
(1.5 Ib/gal
EC)
Issued: 10-01-81
102
APPENDIX III
-3-
-------
AMITRAZ
Listing of Registered Pesticide Products by Formulation
,093.0001 93% technical chemical
amitraz (106201)
001023-00058 045639-00051
,050.0006 50% wettable powder
amitraz (106201)
001023-00061
,101.5012 1.5 Ib/gal emulsifiable concentrate
amitraz (106201)
001023-00059 043142-00045
Issued: 10-01-81 1 Q3
APPENDIX III
-4r-
-------
APPENDIX IV
BIBLIOGRAPHY APPENDICES
104
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and^its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." in the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least -a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
APPENDIX IV
-1- 105
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date\ When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears .immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
APPENDIX IV | Q/
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00028664 Lewis, O.K. (1970) RD 27 419, Plant Biochemistry Report
No. 1: FM 70 158. (Unpublished study received
April 9, 1980 under 431^2-EXl; submitted by Boots
Hercules Agrochemicals Co., Wilmington, DE;
CDL:099371-A)
000.28666 Somerville, L.j Spiers, M.J. (19??) BTS 27 419: Metabolism
in Apple Leaves: AX 72 002. (Unpublished study
received April~9, 1980 under 43142-EX-l; submitted by
Boots Hercules Agrochemicals Co., Wilmington, DE;
CDL:099371-C)
00028667 Boots Hercules Agrochemicals Company (1970) Fate of
14C-BTS 27 419 Applied to Rats as a Single Oral
Dose: Report No. C 71 Oil. (Unpublished study
received April 9, 1980 under 43142-EX-l; submitted
by Boots Hercules Agrocheraicals Co., Wilmington,
DE; CDL:099371-D)
00028668 Boots Hercules Agrochemicals Company (1971) Fate of
14C-BTS 27 419 Applied to Rats as a Single Oral
Dose: Report No. C 71 015. (Unpublished study-
received April 9, 1980 under 43142-EX-l; submitted
by Boots Hercules Agrochemicals Co., Wilmington,
DE; CDL:099371-E)
00028669 Somerville, L. (19??) Fate of 14C-BTS 27 419 Administered
to Rats in Repeated Oral Doses: AX 73011. (Unpub-
lished study received April 9, 1980 under 43142-EX-l;
submitted by Boots Hercules Agrochemicals Co.,
Wilmington, DE; CDL:099371-F)
00028671 Jones, E.M. (1973) Metabolism 14C-BTS 27 419 in Rats:
F 73010. (Unpublished study received April 9, 1980
under 43142-EX1; submitted by Boots Hercules
Agrochemicals Co., Wilmington, DE; CDL:099371-H)
00028672 Boots Hercules Agrochemicals Company (1971) Fate of
14C-BTS 27 419 Applied to Dogs as a Single Oral
Dose. (Unpublished stud,y received April 9, 1980
under 43142-EX-l; CDL:099371-1)
APPENDIX IV 107
-3-
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00028674 Hamilton, D.Y.; Somerville, L. (1974) Fate of 14C-BTS
27 419 When Administered at 15 Mg/Kg to Dogs as a
Single Oral Dose: AX 74006. (Unpublished study
received April 9, 1980 under 43142-EX1; submitted
by Boots Hercules Agrochemicals Co., Wilmington,
DE; CDL:099371-K)
00028675 Somerville, L.; Hughes, K.W. (1973) The Conversion of
BTS 27 419 to BTS 27 271 in the Dog Stomach: AX 73
021. (Unpublished study received April 9, 1980 under
43142-EX-l; submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:099371-L)
00028676 Taylor, J.; Somerville, L. (1977) The Conversion of
Amitraz to BTS 24 868 in Dog Gastric Juice: AX
77010. (Unpublished study received April 9, 1980
under 43142-EX-l; submitted by Boots Hercules Agro-
chemicals Co., Wilmington, DE; CDL:099371-M)
00028682 Somerville, L. (1973) Fate of 14C-BTS 27 419 When
Administered to Cats as a Single Oral Dose: AX 73
018. (Unpublished study received April 9, 1980 under
43142-EX-l; submitted by Boots Agrochemicals Co.,
Wilmington, DE; CDL:099371-S)
00028685 Hamilton, D.Y. (1976) The Fate of 14C-BTS 27419 (Amitraz)
When Administered to Mice at 100 Mg/Kg as a Single
Oral Dose: AX 76013. (Unpublished study received
April 9, 1980 under 43142-EX1; submitted by Boots
Hercules Agrochemicals Co.., Wilmington, DE; CDL:
099371-V)
00028712 Sutton, M.M.; Williams, G.A.H. (1973) BTS 27 419: 90-Day
Toxicity Study in Rats: P71548; C44. (Unpublished
study received April 9, 1980 under 43142-EX-l; submitt
by Boots Hercules Agrochemicals Co., Wilmington,
DE; CDL:099365-A)
00028715 Shaw, J.W.; Williams, G.A.H. (1972?) BTS 27 419: 90-Day
Chronic Toxicity Study in Mice: TX 74 016; C47.
(Unpublished study received April 9, 1980 under
43142-EX-l; submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:099365-D)
APPENDIX IV ^ 08
-4-
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00028716 Patton, D.S.G.; Williams, G.A.H. (19??) BTS 27 419:
90-Day Toxicity Study in Dogs: P71547; C48 .
(Unpublished study received April 9, 1980 under
43142-EX-l; submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:099365-E)
OOQ29459 Everest, R.P.; Wilcox, P.; McCarthy, J.F. (1979) In vitro
Bacterial Mutagenicity Testing of an Amitraz Sample
Containing 1% BTS 33220. (Unpublished study received
March 5, 1980 under 1023-59; prepared in cooperation
with Boots Company, Ltd., submitted by Upjohn Co.,
Kalamazoo, MI; CDL:241968-D)
00029953 Everest, R.P.; Wilcox, P. (1976) BTS 27 419, BTS 27 271,
BTS 27 919 and BTS 28 369: Mutagenicity Testing in
Bacterial in vitro Systems: Report No. TX 76016.
(Unpublished study received April 9, 1980 under
43142-EX-l; submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:099368-C)
00029954 Wilcox, P. (1976) BTS 27 419: Mutagenicity Study in the
Intraperitoneal Host-Mediated Assay: Report No. TX
76028. (Unpublished study received April 9, 1980 under
43142-EX-l; submitted b.y Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL: 099368-D)
00029955 Everest, R.P. (1976) BTS 27 419: Mutagenicity Study in the
Male Mouse Perivisceral Cavity Host-Mediated Assay:
Report No. TX 76056. (Unpublished study received
April 9, 1980 under 43142EX-1; submitted by Boots
Hercules Agrochemicals Co., Wilmington, DE; CDL:
099368-E)
00029957 Palmer, A.K.; James, P.A. (1977) Dominant Lethal Assay of
Araitraz in the Female Mouse: Report No. TX 77020.
(Unpublished study received April 9, 1980 under
43142-EX-l; prepared by Huntingdon Research Centre,
submitted by Boots Hercules Agrochemicals Co.,
Wilmington, DE; CDL:099368-G)
00029958 Palmer, A.K.; James, P.A. (1977) Dominant Lethal Assay of
Amitraz in the Male Mouse: Report No. TX 77021.
(Unpublished study received April 9, 1980 under
43142-EX-l; prepared by Huntingdon Research Centre-
submitted by Boots Hercules Agrochemicals Co.,
Wilmington, DE; CDL:099368-H)
APPENDIX IV 109
-5-
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to tie Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00029959 Sutton, M.M. (19??) BTS 27 419: Teratogenicity in the
Rat: Report No. TX 73028. (Unpublished study >
received April 9, 1980 under 43142-EX-l; submitted by
Boots Hercules Agrochemicals Co., Wilmington, DE;
CDL:099368-I)
000.29960 Sutton, M.M. (19??) BTS 27 419: Effect on Pregnancy,
Parturition and Care of the Young in Rats: Report
No. TX 73031. (Unpublished study received April 9,
1980 under 43142-EX-l; submitted by Boots Hercules
Agrochemicals Co., Wilmington, DE; CDL: 099368-J)
00029961 Sutton, M.M. (19??) BTS 27 419: Teratogenicit./ in the
Rabbit: Report No. TX 73029- (Unpublished study
received April 9, 1980 under 43142-EX-l; submitted by
Boots Hercules Agrochemicals Co., Wilmington, DE;
CDL:099368-K)
00029962 Sutton, M.M. (19??) BTS 27 419: Multigeneration Feeding
Test in Rats: Report No. TX 73036. (Unpublished
study received April 9, 1980 under 43142-EX-l; submits
by Boots Hercules Agrochemicals Co., Wilmington,
DE; CDL:099368-L)
00029963 Berczy, Z.S.; Binns, R.; Newman, A.J. (1972) Acute
Inhalation Toxicity to the Rat of BTS 27419: Report
No. 4971/72/406. (Unpublished study received April
9, 1980 under 43142-EX-l; prepared by Huntingdon
Research Centre, submitted by Boots Hercules Agro-
chemicals Co., Wilmington, DE; CDL:099368-M)
00029972 Sutton, M.M. (1977) BTS 27 419: Three Week Dermal Toxicity
to Rabbits: Report No. TX 73026. (Unpublished
study received April 9, 1980 under 43142-EX-l; submitt
by Boots Hercules Agrochemicals Co., Wilmington,
DE; CDL:099368-V)
00030444 Nissan Chemical Industries, Limited (1972) JA-119 (BTS-2741
Test on Fish Toxicity. (Unpublished study received
April 9, 1980 under 43142-EX-l; submitted b^ Boots
Hercules Agrochemicals Co., Wilmington, DE;
CDL:099369-B)
APPENDIX IV ML)
-6-
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00030445 Fraser, W.D.; Jenkins, G. (1972) The Acute Toxicities
of BTS 27419 (Tech) and BTS 27419 (20% E/C) to
Rainbow Trout under Continuous Flow Conditions:
4880/72/315. (Unpublished study received A^ril 9,
1980 under 43142-EX-l; prepared by Huntingdon Re-
search Centre, submitted by Boots Hercules Agrocheraicals
Co., Wilmington, DE; CDL:099369-D)
00030446 Bentley, R.E. (1975) Acute Toxicity of Technical Amitraz
to Rainbow Trout (Salmo gairdneri). (Unpublished
study received April 9, 1980 under 43142-EX-l; prepared
by Bionomics, EG&G, submitted b^ Boots Hercules
Agrochemicals Co., Wilmington, t>E; CDL: 099369-E)
00030447 Fraser, W.D.; Jenkins, G. (1973) The Acute Toxicities of
Technical and Formulated BTS 27419 to Blue Gill
(Lepomls macrochirus): BTS/73116. (Appendix 4;
unpublished study received April 9, 1980 under 43142-EX-:
prepared by Huntingdon Research Centre, submitted
by Boots Hercules Agrochemicals Co., Wilmington, DE;
CDL:099369-F)
00030448 Fraser, W.D.; Jenkins, G. (1973) The Acute Toxicities
of Technical and Formulated BTS 27419 to Harlequin
Fish (Rasbora heteromorpha) under Continuous Flow
Conditions: BTS/73H7. (Appendix 5; unpublished
study received April 9, 1980 under 43142EX-1; prepared
by Huntingdon Research Centre, submitted by Boots
Hercules Agrochemicals Co., Wilmington, DE; CDL:
099369-G)
00030450 Bentley, R.E. (1973) Acute Toxicity of BTS-27419 Technical
to Grass Shrimp (Palaeomonetes vulgaris) and Fiddler
Crab (Uca pugilator). (Appendix 7; unpublished
study received April 9, 1980 under 43142-EX-l; prepared
by Bionomics, Inc., submitted by Boots Hercules
Agrochemicals Co., Wilmington, DE; CDL: 099369-1)
00030451 Fink, R. (1976) Final Report: Acute Oral LD50-Bobwhite
Quail: Project No. 137-105- (Unpublished study
including unofficial analytical report, received
April 9, 1980 under 43142-EX-l; prepared by Truslow
Farms, Inc., submitted by Boots Hercules Agro-
chemicals Co., Wilmington, DE; CDL:099369-J)
1 1 1
APPENDIX IV
-7-
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00030452 Ross, D.B.; Roberts, N.L. (1973) The Acute Toxicity
(LC50) of BTS 27 419 to Mallard Duck: BTS/73497.
(Appendix 9; unpublished study received April 9, 1980
under 43142-EX-l; prepared by Huntingdon Research
Centre, submitted by Boots Hercules Agrocheraicals
Co., Wilmington, DE; CDL:099369-K)
00030453 Ross, D.B.; Roberts, N.L. (1973) The Acute Toxicity (LG50)
of BTS 27 419 to Japanese Quail: BTS/73498. (Appendix
8; unpublished study received April 9, 1980 under
43142-EX-l; prepared by Huntingdon Research Centre,
submitted by Boots Hercules Agrochemicals Co.,
Wilmington, DE; CDL:099369-L)
00040862 Sutton, M.M.; Williams, P.A. (1972) BTS 27 419: Acute
Dermal Toxicity to Rabbits: YM72011. (Unpublished
study received October 7, 1974 under 5G1558; submitted
by Upjohn Co., Kalamazoo, MI; CDL:094254-1)
00041497 Upjohn Company (1973) Metabolism of 14C-BTS 27 271 in
Dogs: F73019. (Unpublished study received June 24,
1976 under 6F1817; submitted by Upjohn Co., Kalamazoo,
MI; CDL:096423-N)
00041498 Jones, E.M. (1974) Metabolism of 14C-BTS 27 271 in Dogs,
Part 2-Identification of Metabolites in the Retina
and Choroid of the Eye: F74001. (Unpublished study
received June 24, 1976 under 6F1817; submitted by
Upjohn Co., Kalamazoo, MI; CDL:096423-0)
00041499 Hamilton, D.Y.; Somerville, L. (1973) Fate of 14.C-BTS 27 27
When Administered to Dogs as a Single Oral Dose: AX
73 019. (Unpublished study received June 24, 1976
under 6F1817; submitted by Upjohn Co., Kalamazoo,
MI; CDL:096423-P)
00041500 Somerville, L.; Hamilton, D.Y. (1974) Studies on the
Accumulation and Elimination of Radio-Labelled
Residues from Dogs' Eyes following Oral Administration
of 14C-BTS 27 271: AX74013. (Unpublished study
received June 24, 1976 under 6P1817; submitted b.>
Upjohn Co., Kalamazoo, MI; CDL:096423-Q)
00041501 Hamilton, D.Y.; Somerville, L. (1974) Fate of 14C-BTS 28 36;
When Administered at 10 Mg/Kg to Dogs as a Single
Oral Dose: AX74012. (Unpublished study received
June 24, 1976 under 6F1817; submitted by Upjohn Co.,
Kalamazoo, MI; CDL:096423-R)
APPENDIX IV 110
-8- ' ' *•
-------
Appenaix II-2
.OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00041503 Hamilton, D.Y.; Somerville, L. (1974) Fate of 14C-BTS 27 271
When Administered to Cats as a Single Oral Dose: AX
74 005. (Unpublished study received June 24, 1976
under 6F1817; submitted by Upjohn Co., Kalamazoo,
MI; CDL:096423-U)
000.41513 Clegg, D.E. (1973) Residues of BTS27,419 in Animal Tissues.
(Unpublished study received June 24, 1976 under
6F1817; submitted by Upjohn Co., Kalamazoo, MI;
CDL:096423-AH)
00041539 Shaw, J.W. (1973) BTS 27 419: Acute Oral Toxicity to Male
and Female Rats: TXM 73041. (Unpublished study
received June 24, 1976 under 6F1817; submitted by
Upjohn Co., Kalamazoo, MI; CDL:096419-AE)
00044585 Sutton, M.M.; Offer, J. (1973) BTS 27 419: Carcinogenicity
and Long-Term Toxicity Study in Rats: Report TX 73043.
(Unpublished study received June 24, 1976 under 6F1817;
submitted by Upjohn Co., Kalamazoo, MI; CDL:096417-A)
00044586 Moragan, H.E.; Patton, D.S.G.; Turnbull, G.J. (19??). BTS 27
419: Two-Year Oral Toxicity Study in Dogs: TX 73035.
(Unpublished study received June 24, 1976 under 6F1817]
submitted by Upjohn Co., Kalamazoo, MI; CDL:096415-A)
00044591 Kakuk, T.J.; Weddon, T.E. (1976) U-36059: Safety Evaluation
of Baam 1.5 EC in Dogs Foil-owing a Single Topical
Exposure: 527-9610-TJK-76-1. (Unpublished study receiv
October 7, 1974 under 6F1817; submitted by Upjohn Co.,
Kalamazoo, MI; CDL:096415-K)
00046029 Joos, J.L.; Sigetko, J.; Lee, B.L.; et al. (1980) Baam
(R) WP Insecticide for Pears. (Compilation; unpublished
study received July 25, 1980 under 1023-61; submitted
by Upjohn Co., Kalamazoo, MI; CDL:242996-C)
00046030 Nappier, J.L.; Hornish, R.E.; Lane- R.E. (1976) Total
Residue Method for U-36,059 1,5-Di-(2 ,4-dimeth.ylpheny 1)
-3-methyl-l,3,5triazapenta-l,4-diene in Oranges:
Report No. 315-9760-70. Method dated March 24, 1976.
(Unpublished study received July 25, 1980 under
1023-61; submitted by Upjohn Co., Kalamazoo, MI;
CDL:242996-D)
1 13
APPENDIX IV
-9-
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under- the Amitraz Standard
00051717 Holifield, E.L.; Bowers, R.C.; Lee, B.L.j et al. (1975)
Residue Data for Baam on Pears. (Unpublished study
received June 24, 1976 under 6F1817; submitted by
Upjohn Co., Kalamazoo, MI; CDL:096422-E)
00051929 Nappier, J.L.; Hornish, R.E. (1975) Total Residue Method
for U36,059...in Apples, Pears and Soils: Report
No. 315-9760-32. Method dated Sepember 26, 1975.
(Unpublished study received December 18, 1975 under
1023-EX-34; submitted by Upjohn Co., Kalamazoo,
MI; CDL:094993-D)
00051930 Upjohn Company (1975) Comparison of the Analytical Residue
Procedures for U-36,059 and U-40,48l (Used in 1973
and 197^) with the Degradative Procedure (Used in
1975). (Unpublished study received December 18, 1975
under 1023-EX-34; submitted by Upjohn Co., Kalamazoo,
MI; CDL:094993-E)
00055718 Sommerville, L.; Nicholson, J.E. (1977) BTS 27 4l9--Metaboli
in Apples, Variety Cox's Orange Pippin. (Unpublished
study received October 7, -1974 under 5Q1558; submitted
Upjohn Co., Kalamazoo, MI; CDL:094250-C)
00072411 Fink, R.; Beavers, J.B. (1980) Final Report: One-generation
Reproduction Study—Mallard Duck: Project No.
137-113. (Unpublished study received April 9, 1981
under 43142-EX-l; prepared by Wildlife International,
Ltd., submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:244830-A)
00072412 Fink, R.; Beavers, J.B. (1980) Final Report: One-generation
Reproduction Study—Bobwhite Quail: Project No.
137-112. (Unpublished study received April 9, 1981
under 43142-EX-l; prepared by Wildlife International,
Ltd., submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:244831-A)
00074486 Atkins, E.L.; Kellum, D. (1980) Effect of Pesticides on
Apiculture: Maximizing the Effectiveness of Honey
Bees as Pollinators: Project No. 1499. 1980 annual
rept. (Unpublished study received June 8, 1981 under
241-259; prepared by Univ. of California—Riverside,
Citrus Research Center and Agricultural Experiment
Station, Dept. of Entomology, submitted by American
Cyanamid Co., Princeton, N.J.; CDL:070148-G)
APPENDIX IV
-10-
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00111886 Barnett, R.; Crowley, J.; Lessel, B.; et al. (1976)
BTS 27 419: 80-Week Carcinogenicit.y Study in
Mice: Report No. 76059. Final report.
(Unpublished study received June 24, 1976 under
6F1817; prepared by Boots Co., Ltd., submitted
by Upjohn Co., Kalamazoo, MI; CDL: 096416-A)
O0'il4299 Leake, C.; Somerville, L.; Lines, D.; et al. (1982) The Leach
of Amitraz in Four Soil Types Using Soil T.L.C.: METABA
(Unpublished study received Septmber 8, 1982 under 45639-
prepared by FBC, Ltd., England, submitted by BFC Chemica-
Inc., Wilmington, DE; CDL:248318-B)
00139552 Colley, J.; Dawe, S.; Heywood, R.; et al. (1983)
Amitraz: 104'Week Tumorisenicity Study in Mice:
HRC Report No. BTS 153/8262/A; T233. Final Report.
(Unpublished study received January 5, 1984 under
1023-59; prepared by FBC, Ltd., England, submitted
by Upjohn Co., Kalamazoo, MI; CDL:252098-A; 252099;
252100; 252101; 252102)
1 15
APPENDIX IV
-11-
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
GS00234006 .Nor^Am Chemical Company and The Upjohn Chemical
Company (1984) New Data Submitted in Support
•of Registrations of Mitac, Baam and Taktic:
Volume 1 of 3. (Unpublished study received
May 7, 1984 under 45639-49 and 1023-59;
submitted by Nor-Am Chemical Company, Wilming-
ton, DE and The Upjohn Company, Kalamazoo, MI;
CDL:253130)
GS00234007 Nor-Am Chemical Company and The Upjohn Chemical
Company (1984) New Data Submitted in Support
of Registrations of Mitac, Baam and Taktic:
Volume 2 of 3. (Unpublished study received
May 7, 1984 under 45639-49 and 1023-59;
submitted by Nor-Am Chemical Company, Wilming-
ton, DE and The Upjohn Company, Kalamazoo, MI;
CDL:25313D
GS00234011 McGibbon, A.S.; Kelly, I.D. (1984) Metabolism 'Of
[l^C]. amitraz in pears (an interim report).
(Unpublished study received May 2, 1984 under
PP#2F2705/2H5353; submitted by FBC Limited,
Saffron Walden, Essex England; CDL:253132)
GS00234012 McGibbon, A.S.; Kelly, I.D. (1984) The metabolism
pf [l^C] amitraz in lemons under greenhouse
conditions (an interim report). (Unpublished
study received May 2, 1984 under PP#2f2705/
"2H5353; submitted by FBC Limited, Saffron
Walden, Essex England; CDL:253132)
GS00234014 Staten, F.W.; Thornton, A.M. (1975) Frozen stability
of U-36,059 miticide and a metabolite, U-40,48l.
Report No. 315-9760-29. (Unpublished study
received April 22, 1975 under PP#5G1623; submitted
by Upjohn Company, Kalamazoo, MI; CDL:094642)
GS00234015 Nor-Am Chemical Company (1980) Confidential Statement
of Formula for Amitraz Insecticide for
Manufacturing Use Only. In EPA Registration
Jacket 45639-51
GS00234016 The Upjohn Company (1974) Confidential Statement of
Formula for U-36,059 Technical. In EPA Registra-
tion Jacket 1023-58
1 16
APPENDIX IV
-12-
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
030023^021 Douglas, M.T.; Pell, I.E.; North, J.C. (1982) The
Acute Toxicity of Amitraz to Daphnia magna.
(Unpublished study received April 9, 1980
under 45639-EUP-l; submitted by Boots Hercules
Agrochemicals Co., Wilmington, DE; CDL: 099369)
GS000234022 Sleight, B.H. (1973) Acute Toxicity of BTS - 27^19
to Atlantic Oysters (Crassostrea Virglnica).
(Unpublished study received April 9, 1980
under 45639-EUP-l; submitted by Boots Hercules
Agrochemicals Co., Wilmington, DE; CDL: 099369)
APPENDIX IV '
-13-
-------
APPENDIX V
FORMS APPENDICES
118
-------
OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3(C)(2J(8) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposad by the FIFHA action 3(C)(2HB) notice contained in the referenced
Guidance Document. I *m responding in the following manner:
CH I. I will oibmit den in a timely manner to satisfy the following requirements. If the text procedures I will use deviate from (or are not
specified in) the Registration Guideline or the Protocols contained in the Reports of Expert Groups to the Chemicals Group. GECO
Chemicals Testing Programme, I enclose the protocols that I will use:
Q 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(BHii) to tatisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT "~~
D 3. I endow a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4. I request that you amend my registration fay deleting the following uses (this option is not available to applicants (or new products):
Dl I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
REGISTRANTS Al/THOHIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8680-1
APPENDIX
-1-
119
-------
OMB A-pproyal No.
Expires 11/30/89
2070-0057
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To <7u.///V. certify ALL four items) FOR DEVELOPMENT OF DATA
1. 1 am duly authorized lo represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
ACTIVE INGREDIENT
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included in offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
V
NAME OF FIRM
..
DATE OF OFFER « _--
•
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s). if any of the firms named in paragraph (31 above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request
TYPED NAME
SIGNATURE
DATE
EPA Form S58O-6
APPENDIX V
-2-
120
-------
OMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and* am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2)" My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
" and their registration number(s) is/are .
My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, ray firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrants) who have committed
to generate and submit the required data tail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension tor submitting the data.
Registrant's authorized representative:
(Signature)
Dated: '
EPA Form 8570-27 APPENDIX V
-3-
(Typed)
121
-------
PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Regist rat ion
Guideline No.
§158.120 .
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Native of Test
Identity of
ingredients
Statement of
composi t ion
Discussion of
formation of
inared ients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Meltinq point
Boilinq point
Density.- bulk-
density, or
specific qravity
Solub.ility
Vapor pressure
Dissociat ion
constant
Octanol/water
part i tion
coefficient
PH
Test not
requ i red
for my
product
listed
above
( check
below)
I am complying with
data requirements by
Citing MR ID
Number or
EPA Accession
Number
Submit-
t ing
Data
(At-
tached )
( For EPA Use Only)
Accession Numbers
Ass ianed
APPENDIX V
122
-------
«
Registration
Guideline No.[ Name of Test
63-13
63-14
63-15 ."
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Stability
Ox idiz ing/ reducing
reaction
Flammabil i ty
Explodability
Storaae stability
Viscosity
Miscibil ity
Corrosion
character istics
Dielectric break-
down voltaae
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
ir r itation
Dermal sensitiza-
tion
Test not
requ ired
for my
product
listed
above
( check
below)
I am complying with
data requirements by
Citing MRID
Number oc
EPA Accession
•Number
Submi t-
t ing
Data
(At-
tached)
]
( For EPA Use Only)
Accession Numbers
Assigned
APPENDIX V
-5-
123
------- |